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Biguanide

the Control goup Glipizide XL for Diabetes

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 20 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

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

Diabetes
High Blood Sugar

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

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.

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.

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