Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

Type 2 Diabetes Clinical Trial

Official title:

A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/Day

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683657
• Other study ID #: CV181-066
• Secondary ID: Eudract-2008-000
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2008
• Last updated: May 8, 2015
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: May 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaItaly: The Italian Medicines AgencyUnited States: Food and Drug AdministrationSweden: Medical Products AgencySweden: Regional Ethical Review BoardFinland: Finnish Medicines AgencyFinland: Sub-Committee on Medical Research Ethics (TUKIJA)Israel: Ministry of HealthPhilippines: Bureau of Food and DrugsPhilippines: National Ethics CommitteePoland: Cental Evidence of Clinical Research
• Study type: Interventional

Clinical Trial Summary

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

• =18- and =77-years-old

• Type 2 diabetes

• Taking metformin immediate release (IR) or XR =1500 mg for at least 8 weeks as monotherapy

• Glycosylated hemoglobin (A1C) =7% and =10%

• Body mass index (BMI) =40 kg/m2

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
Tablets, Oral, 5mg, once daily, 4 weeks
• Placebo
Tablets, Oral, 0 mg, once daily, 4 weeks

Locations

Country	Name	City	State
Argentina	Local Institution	Martinez	Buenos Aires
Israel	Local Institution	Holon
Israel	Local Institution	Jerusalem
Israel	Local Institution	Kfar-Saba
Israel	Local Institution	Zerifin
Italy	Local Institution	Milano
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Monterrey	Nuevo Leon
Philippines	Local Institution	Cebu City
Philippines	Local Institution	Marikina City
Puerto Rico	Local Institution	Ponce
Sweden	Local Institution	Gothenburg
Sweden	Local Institution	Huddinge
Sweden	Local Institution	Lund
United States	River Birch Research Alliance, Llc	Blue Ridge	Georgia
United States	Amcr Institute, Inc	Escondido	California
United States	Irvine Center For Clinical Research, Inc.	Irvine	California
United States	Jasper Clinic, Inc.	Kalamazoo	Michigan
United States	Avastra Clinical Trials	Midvale	Utah
United States	Clinilabs, Inc.	New York	New York
United States	Dedicated Phase I, Inc.	Phoenix	Arizona
United States	Covance Cru, Inc.	Portland	Oregon
United States	Pacific Sleep Medicine Services (Avastra Clinical Trials)	Redlands	California
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Dgd Research, Inc.	San Antonio	Texas
United States	Advantage Clinical Research	Santa Ana	California
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Israel,  Italy,  Mexico,  Philippines,  Puerto Rico,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 4	No
Secondary	Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4	Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after 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.	Baseline, Week 4	No
Secondary	Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4	Adjusted mean change from baseline in 2-hour postprandial plasma glucose after 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.	Baseline, Week 4	No
Secondary	Change From Baseline in Mean Daily Glucose at Week 4	Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value.	Baseline, Week 4	No
Secondary	Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4	Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value.	Baseline, Week 4	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form