Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

AstraZeneca219 enrolled

Overview

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

219

Conditions

Type 2 Diabetes

Interventions

SaxagliptinDRUG

Tablets, Oral, 5 mg, once daily, 4 weeks

Metformin XRDRUG

Tablets, Oral, 1500 mg, once daily, 4 weeks

Placebo matching Metformin XRDRUG

Tablets, Oral, 0 mg, once daily, 4 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * 18-78 years of age * Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening * Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening * Fasting C-peptide: ≥1.0 ng/mL * FPG≥126 mg/dl obtained at the Day -7 visit * Body mass index (BMI): ≤ 40kg/m² * A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization Exclusion Criteria: * Women of childbearing potential unable or unwilling to use acceptable birth control * Women who are pregnant or breastfeeding * Significant cardiovascular history * Active liver disease * Renal impairment

Locations (21)

Dedicated Phase I, Inc.

Phoenix, Arizona, United States

Pacific Sleep Medicine Services (Avastra Clinical Trials)

Outcomes

Primary Outcomes

Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4

Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.

Time frame: Baseline, Week 4

Secondary Outcomes

Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)

Adjusted mean change from baseline in 2-hour postprandial (after mealtime) plasma glucose two hours after start of the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.

Time frame: Baseline, Week 4

Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal

FPG measurements were done at baseline, day 14 and 28. At baseline and day 28, the FPG value=plasma glucose value collected 30 minutes prior to the morning meal during the domicile visit.

Time frame: Baseline, Week 4

Data from ClinicalTrials.gov

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