Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia

Recruiting in Palo Alto (17 mi)

Overseen byAmbika Babu, MD,MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Cook County Health

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Inclusion Criteria

Target Population

Age and Sex

Men and women aged 18 to 75 years of age.

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Treatment Details

Interventions

Metformin XR (Biguanide)
Saxagliptin (Dipeptidyl Peptidase-4 (DPP-4) Inhibitor)

Participant Groups

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.

Metformin XR is already approved in United States, European Union, Canada, Japan, Australia for the following indications:

🇺🇸 Approved in United States as Glucophage for: