A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

AstraZeneca156 enrolled

Overview

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

156

Conditions

Type 2 Diabetes

Interventions

SaxagliptinDRUG

Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)

PlaceboDRUG

Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)

Metformin (blinded)DRUG

Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus * Drug naive * Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0% * Fasting C-peptide ≥1.0 ng/mL * Body mass index ≤40 kg/m² Exclusion Criteria: * Recent cardiac or cerebrovascular event * Elevated serum creatinine

Locations (3)

Va San Diego Healthcare System

San Diego, California, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Diabetes & Glandular Disease Research Assoc,, Inc.

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12

Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load \[intravenous-oral hyperglycemic clamp (180-480 minutes)\] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.

Time frame: Baseline, Week 12

Secondary Outcomes

Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12

Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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