|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00683657 |
|
Date of registration:
|
21/05/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
|
|
Scientific 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 |
|
Date of first enrolment:
|
July 2008 |
|
Target sample size:
|
93 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00683657 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Argentina
|
Israel
|
Italy
|
Mexico
|
Philippines
|
Puerto Rico
|
Sweden
|
United States
|
|
Contacts
|
|
Name:
|
Bristol-Myers Squibb |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bristol-Myers Squibb |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
77 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Type 2 Diabetes
|
|
Intervention(s)
|
|
Drug: Saxagliptin
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
[Time Frame: Baseline, Week 4]
|
|
Secondary Outcome(s)
|
|
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
[Time Frame: Baseline, Week 4]
|
|
Change From Baseline in Mean Daily Glucose at Week 4
[Time Frame: Baseline, Week 4]
|
|
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
[Time Frame: Baseline, Week 4]
|
|
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
[Time Frame: Baseline, Week 4]
|
|
Secondary ID(s)
|
|
Eudract-2008-000976-26
|
|
CV181-066
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|