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Biguanide

the Control goup Glipizide XL for High Blood Sugar

Phase 4
Waitlist Available
Led By Ambika Babu, MD,MS
Research Sponsored by Cook County Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Target Population
Age and Sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels 300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or occurrence of severe hypoglycemia compared to glipizide XL. The study may provide preliminary evidence to support the role of S+M as a bridging, stabilizing and safe therapy in patients with severe hyperglycemia

Eligible Conditions
  • High Blood Sugar
  • Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of responders in each arm. Responder: FBG 70-300 and/or PPBG <400 mg/dl (week1-6), FBG 70-250 and/or PPBG <300 mg/dl (week 7-12) and without metabolic exclusion criteria, repeat ED visits, hospitalization or significant hypoglycemia.
Secondary outcome measures
Percentage of patients with symptomatic hypoglycemia
Proportion of patients achieving FBG goal of 70-130 mg/dl at 12 weeks in the 2 treatment arms
The number of fold increase in beta cell function in the 2 arms.
+1 more

Trial Design

2Treatment groups
Active Control
Group I: the Control goup Glipizide XLActive Control1 Intervention
The control group will receive Sulphonylurea (Glipizide XL 10mg orally) for a total duration of 12 weeks.
Group II: Saxagliptin + Metformin XRActive Control2 Interventions
Saxagliptin 5 mg + Metformin XR 1000 mg will be automatically titrated weekly in 2 weeks to Saxagliptin 5 mg + Metformin XR 2000 daily for a total duration of 12 weeks.

Find a Location

Who is running the clinical trial?

Cook County HealthLead Sponsor
46 Previous Clinical Trials
16,095 Total Patients Enrolled
John H. Stroger HospitalLead Sponsor
42 Previous Clinical Trials
13,025 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,436 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~10 spots leftby Mar 2025