Kombiglyze Xr

Physical Activity, Type 2 Diabetes, Diet + 4 more

Treatment

7 FDA approvals

20 Active Studies for Kombiglyze Xr

What is Kombiglyze Xr

Saxagliptin

The Generic name of this drug

Treatment Summary

Metformin is a drug used to treat type 2 diabetes. It is the most commonly prescribed drug for this condition and is used by at least 120 million people worldwide. Metformin helps to lower blood sugar without causing low blood sugar and can also improve insulin sensitivity, leading to a decrease in insulin resistance and lower plasma fasting insulin levels. Additionally, it can cause modest weight loss. Metformin was approved in Canada in 1972 and in the United States in 1995. It is available in regular and extended-release forms.

Onglyza

is the brand name

image of different drug pills on a surface

Kombiglyze Xr Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Onglyza

Saxagliptin

2009

19

Approved as Treatment by the FDA

Saxagliptin, also known as Onglyza, is approved by the FDA for 7 uses which include Type 2 Diabetes Mellitus and Physical Activity .

Type 2 Diabetes Mellitus

Used to treat Type 2 Diabetes Mellitus in combination with Metformin

Physical Activity

Used to treat Exercise in combination with Metformin

Excercise

Used to treat Excercise in combination with Dapagliflozin

Type 2 Diabetes

Used to treat Type 2 Diabetes Mellitus in combination with Metformin

saxagliptin

Used to treat already treated with dapagliflozin and saxagliptin in combination with Dapagliflozin

dapagliflozin

Used to treat inadequate control with dapagliflozin in combination with Dapagliflozin

Diet

Used to treat Diet in combination with Metformin

Effectiveness

How Kombiglyze Xr Affects Patients

Insulin is a hormone that helps control the amount of sugar in the blood. People with type 2 diabetes can either be resistant to insulin, meaning they don't respond to it as well, or they may not produce enough insulin. Metformin works by reducing the amount of sugar produced by the liver, limiting how much sugar is absorbed from food, and making cells more sensitive to insulin. Unlike other diabetes drugs, Metformin doesn't increase the amount of insulin in your body. In one study, people taking Metformin saw their fasting plasma glucose levels go down by 59 mg/dL on average, compared to an average increase of

How Kombiglyze Xr works in the body

Metformin works differently than other diabetes medications by decreasing the body's production of glucose, reducing glucose absorption in the intestines, and increasing insulin sensitivity. When taken, metformin accumulates in cells and the mitochondria, where it inhibits mitochondrial complex I and activates AMP-activated protein kinase. This enzyme helps regulate glucose metabolism by inhibiting fat synthesis, increasing fat oxidation, and reducing liver lipid stores, making it more sensitive to insulin. Metformin also increases the metabolism of glucose in the intestines, leading to reduced net glucose uptake and increased lactate delivery to the liver. It also promotes the metabolism of glucose

When to interrupt dosage

The measure of Kombiglyze Xr is contingent upon the established disorder, including Diet, inadequate response to metformin and Diabetic Ketoacidosis. The amount of dosage deviates, dependent on the method of delivery (e.g. Oral or Tablet - Oral) featured in the table beneath.

Condition

Dosage

Administration

Physical Activity

2.5 mg, , 5.0 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Tablet - Oral, Tablet

Type 2 Diabetes

2.5 mg, , 5.0 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Tablet - Oral, Tablet

Diet

2.5 mg, , 5.0 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Tablet - Oral, Tablet

saxagliptin

2.5 mg, , 5.0 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Tablet - Oral, Tablet

inadequate response to other therapeutic measures

2.5 mg, , 5.0 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Tablet - Oral, Tablet

Excercise

2.5 mg, , 5.0 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Tablet - Oral, Tablet

dapagliflozin

2.5 mg, , 5.0 mg

Oral, Tablet, film coated, Tablet, film coated - Oral, , Tablet, film coated, extended release - Oral, Tablet, film coated, extended release, Tablet - Oral, Tablet

Warnings

There are 20 known major drug interactions with Kombiglyze Xr.

Common Kombiglyze Xr Drug Interactions

Drug Name

Risk Level

Description

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Saxagliptin.

Axitinib

Major

The metabolism of Axitinib can be decreased when combined with Saxagliptin.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Saxagliptin.

Carbamazepine

Major

The metabolism of Carbamazepine can be decreased when combined with Saxagliptin.

Clonidine

Major

The metabolism of Clonidine can be decreased when combined with Saxagliptin.

Kombiglyze Xr Toxicity & Overdose Risk

The toxic dose of Metformin in rats is 1g/kg orally, 500mg/kg intraperitoneally and 300mg/kg subcutaneously. In mice, the toxic dose is 1450mg/kg orally, 420mg/kg intraperitoneally and 225mg/kg subcutaneously. Metformin may lead to lactic acidosis, a condition where lactate levels are higher than normal in the blood. Symptoms may include malaise, muscle pain, abdominal pain, respiratory distress and increased sleepiness. There is an increased risk of lactic acidosis in those with reduced kidney function

image of a doctor in a lab doing drug, clinical research

Kombiglyze Xr Novel Uses: Which Conditions Have a Clinical Trial Featuring Kombiglyze Xr?

346 active studies are presently examining the potential of Kombiglyze XR to alleviate Type 2 Diabetes, Type 1 Diabetes and an inadequate response to Metformin therapy.

Condition

Clinical Trials

Trial Phases

inadequate response to other therapeutic measures

0 Actively Recruiting

saxagliptin

0 Actively Recruiting

Diet

5 Actively Recruiting

Not Applicable, Phase 1

Type 2 Diabetes

167 Actively Recruiting

Not Applicable, Phase 1, Phase 2, Phase 3, Phase 4, Early Phase 1

Excercise

1 Actively Recruiting

Not Applicable

dapagliflozin

0 Actively Recruiting

Physical Activity

24 Actively Recruiting

Not Applicable, Phase 1, Phase 2

Kombiglyze Xr Reviews: What are patients saying about Kombiglyze Xr?

5

Patient Review

3/25/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

I've only been on the medication for a short time, but I've already experienced lower abdominal pain, as well as left shoulder and body aches. I'm wondering how long I should give it before deciding if it's effective or not. My blood sugar levels haven't dropped significantly yet.

5

Patient Review

7/2/2014

Kombiglyze Xr for Type 2 Diabetes Mellitus

At first, I experienced some stomach problems, but they dissipated after about a month. My A1C was 10.5 when I started this treatment, and after only four months it had lowered to 7. And all without having to diet or exercise!

5

Patient Review

9/10/2016

Kombiglyze Xr for Type 2 Diabetes Mellitus

Kombiglyze was a much better fit for me than metformin and glipizide. My A1C levels dropped significantly, and my blood sugar was more consistent throughout the day. I also didn't have any episodes of hypoglycemia like I did with glipizide.

5

Patient Review

4/6/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

I just started taking this, and it is quite expensive. One review I read mentioned a card used to register with the manufacturer; apparently, it reduced her cost to $10 per month. I would love to know more about this program!

5

Patient Review

6/2/2014

Kombiglyze Xr for Type 2 Diabetes Mellitus

I haven't been thrilled with this treatment so far as it's made me quite ill; however, I'm hoping my body will adjust to it in the next week or so.

4.3

Patient Review

6/6/2016

Kombiglyze Xr for Type 2 Diabetes Mellitus

Kombiglyze helped improve my A1c marginally more than Metformin did when used as a supplement to injected insulin. I will have to reassess whether or not I want to continue using it due to the cost, although there were no negative side effects that I experienced.

4

Patient Review

2/8/2015

Kombiglyze Xr for Type 2 Diabetes Mellitus

I would not recommend this drug to anyone. It caused a lot of problems for me, including heart and brain damage. I was on it for almost four years and experienced severe insomnia, memory loss, muscle pain, and constant trips to the bathroom. I'm only off now because of the anxiety and nausea it caused.

4

Patient Review

1/2/2017

Kombiglyze Xr for Type 2 Diabetes Mellitus

I've been taking this medicine for the past four years and, while it has helped to control my sugar levels, I have noticed a significant decline in my sex life.

4

Patient Review

3/6/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

I'm experiencing some serious leg cramps in my right lower leg. I'm not sure if it's a side effect of the medicine, but I'll be sure to ask my doctor about it.

4

Patient Review

1/13/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

3.7

Patient Review

1/23/2014

Kombiglyze Xr for Type 2 Diabetes Mellitus

I've found this medication really helpful in dropping the pounds. With a solid workout routine and healthy eating habits, I was able to lose 50 pounds while taking this drug.

3.7

Patient Review

1/13/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

3.3

Patient Review

6/29/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

As a 47-year old male, Glucophage didn't lower my blood sugar levels enough. Therefore, the doctor put me on this medication. I found that drinking lots of water helped with any headaches I got and that stomach issues only lasted about three weeks. It's important to take this drug with food, as it is much more effective that way. I also found that aspartame caused bad gas pains, but Splenda did not.

3

Patient Review

3/6/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

I take one metformin pill in the morning and one at night, along with Kombiglyze. My sugars have improved noticeably without any side effects.

3

Patient Review

1/19/2013

Kombiglyze Xr for Type 2 Diabetes Mellitus

1.3

Patient Review

9/27/2015

Kombiglyze Xr for Type 2 Diabetes Mellitus

I've been on this for about a month and it's helped, but I've also experienced some pretty nasty side effects like constipation, diarrhea, and headaches. I'm concerned about the potential long-term effects of this medication on my pancreas.

1

Patient Review

8/18/2014

Kombiglyze Xr for Type 2 Diabetes Mellitus

Even though all medications have potential side effects, I found this one to be very effective. My AC1 levels decreased within three months and it didn't cause any stomach upset.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about kombiglyze xr

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the generic for kombiglyze?

"There are no alternative medicines to Kombiglyze XR at the moment."

Answered by AI

Is kombiglyze the same as Janumet?

"It’s more expensive than some other diabetes drugs but worth the price.

Kombiglyze lower blood sugar levels effectively, but may not be a good choice of medication if you have heart or kidney problems. Janumet is a combination of two anti-diabetic medicines that work better together, but is only available as a brand name drug. It is more expensive than some other diabetes medications, but is worth the price."

Answered by AI

What is KOMBIGLYZE XR used for?

"KOMBIGLYZE XR is a prescription medicine that contains saxagliptin and metformin hydrochloride. KOMBIGLYZE XR is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes. Your doctor will decide if treatment with KOMBIGLYZE XR is right for you."

Answered by AI

Is kombiglyze the same as metformin?

"Metformin can cause a serious condition called lactic acidosis, which is a build-up of an acid in the blood. Lactic acidosis is a medical emergency and requires hospital treatment."

Answered by AI

Clinical Trials for Kombiglyze Xr

Image of Faculty of Health Sciences in Winnipeg, Canada.

Saskatoon Berries for Type 2 Diabetes

18 - 74
All Sexes
Winnipeg, Canada

Diabetes becomes epidemic in worldwide countries. Diabetes Canada indicated that 30% of adults in Manitoba are diabetes or prediabetes. Nine out of ten diabetic patients are type 2 diabetes (T2D). T2D is characterized by insulin resistance and obesity. Uncontrolled diabetes leads to serious consequences including heart attack, stroke, chronic renal failure, liver failure, blindness and low limb amputation. Most of hypoglycemic medications have certain side effects. Natural foods or nutraceuticals with hypoglycemic potential are expected to provide a safer management for diabetic patients. Saskatoon berry is a popular fruit in Canadian Prairie and Northern states in USA. Our previous studies demonstrated Saskatoon berry (SB) powder attenuated hyperglycemia, hyperlipidemia, insulin resistance, inflammation, liver steatosis and gut dysbiosis in diet-induced insulin resistant mice, a model for T2D. The findings of the glucose and lipid lowering or liver protective effects of SB powder have been supported by another group in Australia in high fat fed rats. Our preliminary studies in 20 healthy subjects demonstrated that dried whole SB (40 g/day for 10 weeks) significantly reduced fasting plasma glucose, total and LDL-cholesterol, systolic blood pressure, and increased plasma glucagon-like peptide compared to baseline, which was associated with increased intake of total fiber and decreased intake of saturated fat. The changes in metabolic and vascular variables significantly correlated with the alterations in gut microbiota The combination of findings suggest that SB is good candidate of prebiotic functional food as a supplemental remedy for reducing the risk for metabolic syndrome and preventing or managing T2D. The effect of Saskatoon berry and its products on metabolic disorders have not been studied in diabetic subjects. We propose to examine the effects of oral administration of freeze-dried whole SB on glucose metabolism, insulin resistance and gut microbiota in untreated prediabetes and new type 2 diabetic patients compared to a control dried fruit in a randomized controlled trial.

Waitlist Available
Dietary Supplement

Faculty of Health Sciences

Image of Central Research Associates - Flourish - PPDS in Birmingham, United States.

CX11 for Type 2 Diabetes

18 - 75
All Sexes
Birmingham, AL

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Phase 2
Waitlist Available

Central Research Associates - Flourish - PPDS (+29 Sites)

Corxel Pharmaceuticals

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Adaptive Dietary Intervention for Type 2 Diabetes

18+
All Sexes
New York, NY

The investigators will examine the feasibility, acceptability, and effect of an adaptive dietary intervention over 24 weeks (12-week intervention, 12-week follow-up) among Asian Americans with Type 2 diabetes. Participants (N=120; 60 Chinese Americans and 60 Vietnamese Americans) will be 2:1 randomized to one of two arms: adaptive dietary intervention or standard of care (SC). The intervention will begin with continued glucose monitoring (CGM) use only during weeks 0-4. At week 4, participants who achieve the glycemic control goal (at least an 8% increase in time in range \[TIR\] from baseline) will continue with the CGM alone during weeks 4-12 ("CGM Alone"); otherwise, culturally and linguistically adapted glucose excursion minimization (GEM) will be augmented with CGM ("CGM-GEM").

Waitlist Available
Has No Placebo

NYU Langone Health

Yaguang Zheng, PhD, RN

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MetSense Risk Flag for Type 2 Diabetes

18+
All Sexes
Pleasanton, CA

People with serious mental illness have high risk for type 2 diabetes due to multiple risk factors, including the metabolic side effects of psychotropic medications that are used to treat these conditions. Type 2 diabetes is preventable through lifestyle and pharmacological interventions, but many people with serious mental illness do not receive regular screening for type 2 diabetes risk. In many health care settings, clinical pharmacists are increasingly managing patients with serious mental illness and have expertise in monitoring the metabolic side effects of psychotropic medications. This study evaluates the feasibility and acceptability of using a diabetes prediction model that is based on electronic health record data (the MetSense risk flag) to alert clinical pharmacists about patients who are at high diabetes risk, prompting these clinicians to prioritize diabetes risk management services.

Waitlist Available
Has No Placebo

KPNC Division of Research

Esti Iturralde, PhD

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Tailored DPP for Prediabetes

17 - 25
All Sexes
Los Angeles, CA

The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity. The specific aims are: Aim 1 - Evaluate the efficacy of an AYA-tailored version of the UC DPP for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months). Aim 2 - Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP. The investigators will recruit 80 UCLA undergraduate students. Participants will be asked to complete a brief screening online form to assess eligibility and to collect contact information. The PI and/or Research Assistants (RAs) will reach out to eligible participants to obtain informed consent and enroll them in the pilot trial. The investigators will randomize participants to the tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the tailored DPP in the following academic year. The tailored DPP intervention will be online and asynchronously. Participants will be asked to complete the intervention lessons on their own time. Each lesson typically takes on average 15 minutes to complete. Control group will receive each intervention materials via e-mail for participants to review on their own time and will receive acceptability surveys. The interventions for the control group will be remote. A research assistant will meet with control participants via Zoom to explain the intervention materials. Control group will receive access to a study habits intervention, alcohol use intervention, and financial literacy intervention. At the end of each quarter (Fall, Winter, and Spring), both control and intervention participants will receive an email with a unique link to a brief REDCap survey to ascertain acceptability of sessions/lessons. Furthermore, participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey.

Recruiting
Has No Placebo

University of California, Los Angeles

Lauren E Wisk, PhD

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