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A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
placebo
taspoglutide
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;
  • HbA1c >=6.5% and <=9.5% at screening;
  • BMI >=30 and <=50 kg/m2 at screening;
  • stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion Criteria:

  • history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
  • evidence of clinically significant diabetic complications;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

taspoglutide

Arm Description

Outcomes

Primary Outcome Measures

Absolute change from baseline in HbA1c

Secondary Outcome Measures

Change from baseline in body weight;% of patients achieving >=5% weight loss
% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function
Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n

Full Information

First Posted
January 15, 2009
Last Updated
July 26, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00823992
Brief Title
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
taspoglutide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
sc once weekly
Intervention Type
Drug
Intervention Name(s)
taspoglutide
Intervention Description
10mg sc once weekly for 4 weeks, then 20mg sc once weekly
Primary Outcome Measure Information:
Title
Absolute change from baseline in HbA1c
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in body weight;% of patients achieving >=5% weight loss
Time Frame
24 weeks
Title
% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function
Time Frame
24 weeks
Title
Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n
Time Frame
At planned clinic visits, for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, 18-75 years of age; type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks; HbA1c >=6.5% and <=9.5% at screening; BMI >=30 and <=50 kg/m2 at screening; stable weight +/-5% for at least 12 weeks prior to screening. Exclusion Criteria: history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months; evidence of clinically significant diabetic complications; myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Bermuda Dunes
State/Province
California
ZIP/Postal Code
92203
Country
United States
City
Lajolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08753
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
City
Springfield Gardens
State/Province
New York
ZIP/Postal Code
11413
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Midland
State/Province
Texas
ZIP/Postal Code
79707
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78237
Country
United States
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
City
Sherbrooke
State/Province
Nova Scotia
ZIP/Postal Code
J1G 2E8
Country
Canada
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
City
Berlin
ZIP/Postal Code
10115
Country
Germany
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
City
Mainz
ZIP/Postal Code
55116
Country
Germany
City
Münster
ZIP/Postal Code
48145
Country
Germany
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
City
Ancona
ZIP/Postal Code
60131
Country
Italy
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
City
Roma
ZIP/Postal Code
00161
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Bitola
ZIP/Postal Code
7000
Country
Macedonia, The Former Yugoslav Republic of
City
Gniewkowo
ZIP/Postal Code
88-140
Country
Poland
City
Kamieniec Zabkowicki
ZIP/Postal Code
57-230
Country
Poland
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
City
Carolina
ZIP/Postal Code
00983
Country
Puerto Rico
City
Rio Grande
ZIP/Postal Code
00745
Country
Puerto Rico
City
Rio Piedras
ZIP/Postal Code
00921
Country
Puerto Rico
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410002
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
City
Tumen
ZIP/Postal Code
625023
Country
Russian Federation
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Lerida
ZIP/Postal Code
25198
Country
Spain
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
City
Bath
ZIP/Postal Code
BA2 4BY
Country
United Kingdom
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G45 9AW
Country
United Kingdom
City
Midsomer Norton
ZIP/Postal Code
BA3 2UH
Country
United Kingdom
City
Rotherham
ZIP/Postal Code
S65 1DA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

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