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Dapagliflozin + Pioglitazone for Type 1 Diabetes
Phase 4
Recruiting
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable insulin dose (±4 units) in the preceding three months.
Total daily insulin dose ≥0.6 U/kg per day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights
Study Summary
This trial is examining the effect of adding the diabetes drugs dapagliflozin and pioglitazone to insulin on glucose control and ketone levels in people with type 1 diabetes.
Who is the study for?
Adults over 18 with Type 1 Diabetes, HbA1c levels between 7.0-11.0%, and on a stable insulin dose can join this trial. They should be in good health, not heavily exercising, or planning pregnancy. Excluded are those sensitive to the drugs tested, with kidney issues (eGFR<60), other major diseases, recent severe diabetes complications, or on glucose-affecting meds besides insulin.Check my eligibility
What is being tested?
The study tests if adding dapagliflozin and pioglitazone to insulin therapy improves blood sugar control in Type 1 Diabetes without increasing ketoacidosis or hypoglycemia risk. Participants will first take dapagliflozin for 12 weeks then randomly get either pioglitazone or placebo for another 16 weeks.See study design
What are the potential side effects?
Possible side effects include sensitivity reactions to medication components, low blood sugar episodes (hypoglycemia), increased ketones which could lead to ketoacidosis (a serious condition where the body produces high levels of blood acids), and urinary issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My insulin dose has been stable for the last 3 months.
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I take 0.6 units or more of insulin per kilogram of my body weight daily.
Select...
I am older than 18 years.
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I have been diagnosed with Type 1 Diabetes.
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I use an insulin pump or take multiple daily insulin injections.
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I have type 1 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease in HbA1c
Secondary outcome measures
insulin dose
plasma ketones
Side effects data
From 2013 Phase 3 trial • 936 Patients • NCT0118301310%
Oedema peripheral
9%
Hypertension
9%
Back pain
7%
Nasopharyngitis
7%
Hyperglycaemia
5%
Urinary tract infection
5%
Headache
4%
Pain in extremity
4%
Bronchitis
3%
Oedema
2%
Diarrhoea
2%
Arthralgia
2%
Upper respiratory tract infection
1%
Pneumothorax
1%
Pancreatitis acute
1%
Rectosigmoid cancer
1%
Hairy cell leukaemia
1%
Jaundice
1%
Myocardial infarction
1%
Intestinal haemorrhage
1%
Pneumonia
1%
Small intestine carcinoma
1%
Bipolar disorder
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pio15/Pio30
Pio30/Pio30
Pio45/Pio45
Lina5/Lina5
Lina5Pio15/Lina5Pio30
Lina5Pio30/Lina5Pio30
Lina5Pio45/Lina5Pio45
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
pioglitazone treatment
Group II: controlPlacebo Group1 Intervention
subjects will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pioglitazone 45 mg
2000
Completed Phase 4
~960
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,290 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced.My insulin dose has been stable for the last 3 months.I am allergic to dapagliflozin or pioglitazone.I do not have major organ diseases, a history of serious illness, or take medication affecting glucose, other than insulin.I take 0.6 units or more of insulin per kilogram of my body weight daily.Your HbA1c level is not between 7.0% and 11.0%.You are following a ketogenic diet.I am older than 18 years.Your blood sugar levels are not well controlled (HbA1c is between 7.0% and 11.0%).I am using two forms of birth control.I have been diagnosed with Type 1 Diabetes.Your fasting C-peptide level is higher than 0.7 ng/ml.I use an insulin pump or take multiple daily insulin injections.I have type 1 diabetes.I am in good overall health.Blood in the urine.I haven't been hospitalized for diabetes issues like DKA, low or high blood sugar in the last 6 months.You are currently taking part in a very intense exercise program.My insulin dose has been stable for the last 3 months.I have been diagnosed with type 2 diabetes.Your C-peptide level is less than 0.7 ng/ml when fasting.Your weight has not changed by more than 3 pounds in the last 3 months.Your eGFR (a measure of kidney function) is at least 60 milliliters per minute.My daily insulin dose is less than 0.6 units per kilogram.I experience symptoms like excessive thirst or urination due to poor blood sugar control.I have a severe form of diabetic eye disease.
Research Study Groups:
This trial has the following groups:- Group 1: control
- Group 2: Intervention
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of participants engaged in this research?
"Affirmative. Clinicaltrials.gov records suggest that this medical experiment, which was initially posted on August 8th 2019, is currently accepting participants. Around 120 volunteers must be sourced from one hospital facility."
Answered by AI
Has the United States Food & Drug Administration approved Pioglitazone 45 mg?
"This drug has been approved and there is ample evidence supporting its safety, thus it was allocated a rating of 3."
Answered by AI
Are recruitments still open for this research trial?
"The clinical trial is in search of participants, as per the information listed on clinicaltrials.gov. The medical study was initiated on August 8th 2019 and has recently been updated on February 3rd 2022."
Answered by AI
Has research in the past been conducted on Pioglitazone 45 mg?
"Currently, there are 31 Pioglitazone 45 mg clinical trials in operation worldwide. Of these, 4 have advanced to stage 3 and the majority of them originated in Lausanne, Vaud; however, 69 other locations have also been conducting research into this drug."
Answered by AI
What conditions warrant a prescription of Pioglitazone 45 mg?
"Pioglitazone 45 mg is an effective tool for managing diabetes, alleviating symptoms of diabetic neuralgia, and maintaining dietary objectives."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University Health System Texas Diabetic Institute
What portion of applicants met pre-screening criteria?
Met criteria
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