A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744926
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: placebo Drug: taspoglutide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
sc, once weekly

Experimental: taspoglutide 10mg sc Drug: taspoglutide
10mg sc, once weekly

Experimental: taspoglutide 10mg/20mg sc Drug: taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)

Primary Outcome Measures :
  1. Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. [ Time Frame: Throughout study ]
  2. Change from baseline in fasting plasma glucose; change from baseline in body weight. [ Time Frame: 24 weeks ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744926

  Hide Study Locations
United States, Arizona
Phoenix, Arizona, United States, 85015
United States, California
Los Angeles, California, United States, 90057
Santa Ana, California, United States, 92701
United States, Indiana
Avon, Indiana, United States, 46123
United States, Nevada
Pahrump, Nevada, United States, 89048
United States, North Carolina
Charlotte, North Carolina, United States, 28211
United States, South Carolina
Greer, South Carolina, United States, 29651
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
San Antonio, Texas, United States, 78237
United States, Virginia
Richmond, Virginia, United States, 23294
Adelaide, Australia, 5000
St. Leonards, Australia, 2065
Guatemala, Guatemala, 01010
Guatemala, Guatemala, 01014
Haifa, Israel, 31096
Haifa, Israel, 34162
Holon, Israel, 58100
Jerusalem, Israel, 91200
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 49100
Tel Aviv, Israel, 64239
Acapulco, Mexico, 39670
Aguascalientes, Mexico, 20230
Chihuahua, Mexico, 31238
Hermosillo, Mexico, 83200
Mexico City, Mexico, 11650
Morelia, Mexico, 58000
Lima, Peru, Lima 33
San Isidro, Peru, 27
Bucuresti, Romania, 020359
Buzau, Romania, 120203
Cluj-napoca, Romania, 400006
Ploiesti, Romania, 100163
Ploiesti, Romania, 100342
Tg. Mures, Romania, 540142
Russian Federation
Chelyabinsk, Russian Federation, 454136
Jaloslave, Russian Federation
Moscow, Russian Federation, 109263
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 119048
Moscow, Russian Federation, 129110
S. Petersburg, Russian Federation, 195067
S.petersburg, Russian Federation, 194017
St. Petersburg, Russian Federation, 191124
Yaroslavl, Russian Federation, 150062
Dolny Kubin, Slovakia, 02601
Levice, Slovakia, 034 01
Presov, Slovakia, 080 01
Trencin, Slovakia, 911 01
Zilina, Slovakia, 010 01
Changhua, Taiwan, 500
Tainan, Taiwan, 710
Taipei, Taiwan, 100
Tapei County, Taiwan, 231
Chernovtsy, Ukraine, 58002
Kiev, Ukraine, 01601
Kiev, Ukraine, 04050
Lviv, Ukraine, 79010
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00744926     History of Changes
Other Study ID Numbers: BC20750
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs