Back to resultsA Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
placebo
taspoglutide
taspoglutide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility Criteria
Inclusion Criteria:
- adult patients, 18-80 years of age;
- drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
- tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
- C-peptide (fasting) >=1.0ng/mL
- HbA1c >=6.5% and <=10.0% at screening;
- BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;
- stable weight +/- 5% for at least 12 weeks prior to screening.
Exclusion Criteria:
- history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
- evidence of clinically significant diabetic complications;
- symptomatic poorly controlled diabetes;
- myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
- known hemoglobinopathy or chronic anemia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
placebo
taspoglutide 10mg sc
taspoglutide 10mg/20mg sc
Arm Description
Outcomes
Primary Outcome Measures
Absolute change from baseline in HbA1c
Secondary Outcome Measures
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Change from baseline in fasting plasma glucose; change from baseline in body weight.
Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00744926
Brief Title
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide Compared to Placebo, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 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 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 1 year, 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
373 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
taspoglutide 10mg sc
Arm Type
Experimental
Arm Title
taspoglutide 10mg/20mg sc
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
Intervention Type
Drug
Intervention Name(s)
taspoglutide
Intervention Description
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
Primary Outcome Measure Information:
Title
Absolute change from baseline in HbA1c
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Time Frame
Throughout study
Title
Change from baseline in fasting plasma glucose; change from baseline in body weight.
Time Frame
24 weeks
Title
Responder rates for HbA1c (target <=7.0%, <=6.5%); relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, 18-80 years of age;
drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
C-peptide (fasting) >=1.0ng/mL
HbA1c >=6.5% and <=10.0% at screening;
BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;
stable weight +/- 5% for at least 12 weeks prior to screening.
Exclusion Criteria:
history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
evidence of clinically significant diabetic complications;
symptomatic poorly controlled diabetes;
myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
known hemoglobinopathy or chronic anemia.
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
City
Pahrump
State/Province
Nevada
ZIP/Postal Code
89048
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78237
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
City
St. Leonards
ZIP/Postal Code
2065
Country
Australia
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
City
Guatemala
ZIP/Postal Code
01014
Country
Guatemala
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Haifa
ZIP/Postal Code
34162
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Jerusalem
ZIP/Postal Code
91200
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Acapulco
ZIP/Postal Code
39670
Country
Mexico
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
City
Hermosillo
ZIP/Postal Code
83200
Country
Mexico
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
City
Morelia
ZIP/Postal Code
58000
Country
Mexico
City
Lima
ZIP/Postal Code
Lima 33
Country
Peru
City
San Isidro
ZIP/Postal Code
27
Country
Peru
City
Bucuresti
ZIP/Postal Code
020359
Country
Romania
City
Buzau
ZIP/Postal Code
120203
Country
Romania
City
Cluj-napoca
ZIP/Postal Code
400006
Country
Romania
City
Ploiesti
ZIP/Postal Code
100163
Country
Romania
City
Ploiesti
ZIP/Postal Code
100342
Country
Romania
City
Tg. Mures
ZIP/Postal Code
540142
Country
Romania
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
City
Jaloslave
Country
Russian Federation
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
S. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
City
S.petersburg
ZIP/Postal Code
194017
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
191124
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
City
Dolny Kubin
ZIP/Postal Code
02601
Country
Slovakia
City
Levice
ZIP/Postal Code
034 01
Country
Slovakia
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Tapei County
ZIP/Postal Code
231
Country
Taiwan
City
Chernovtsy
ZIP/Postal Code
58002
Country
Ukraine
City
Kiev
ZIP/Postal Code
01601
Country
Ukraine
City
Kiev
ZIP/Postal Code
04050
Country
Ukraine
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
12. IPD Sharing Statement
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A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
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