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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Saxagliptin; Drug: Metformin (blinded); Drug: Metformin (open-label)

• Registration Number: NCT00374907
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-12
• Primary Completion: 2008-01
• Disposition First Submitted: 2009-07-30
• Study Completion: 2009-12
• Disposition First Submitted QC: 2010-08-13
• Disposition First Posted: 2010-08-18
• Results First Submitted: 2010-12-26
• Results First Submitted QC: 2010-12-26
• Results First Posted: 2011-01-21
• Status Verified: 2015-03
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (ST) / Metformin (LT) (B)	Placebo	Metformin 500-1500 mg (open-label, as needed for rescue in LT)
Placebo (ST) / Metformin (LT) (B)	Metformin (blinded)	Metformin 500-1500 mg (open-label, as needed for rescue in LT)
Placebo (ST) / Metformin (LT) (B)	Metformin (open-label)	Metformin 500-1500 mg (open-label, as needed for rescue in LT)
Saxagliptin (A)	Saxagliptin	Metformin 500-1500 mg (open-label, as needed for rescue in LT)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12	Baseline, 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.

Trial Locations

Locations (3)

Diabetes & Glandular Disease Research Assoc,, Inc.; 🇺🇸 San Antonio, Texas, United States

Va San Diego Healthcare System; 🇺🇸 San Diego, California, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States