A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

August 3, 2016 updated by: Hoffmann-La Roche

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone

This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. 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 1-2 years, and the target sample size is 100-500 individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Brasilia, Brazil, 70390-155
      • Forlateza, Brazil, 60430-350
      • Fortaleza, Brazil, 60155-290
      • Fortaleza, Brazil, 60430-370
      • Fortaleza, Brazil, 60120-021
      • Mogi Das Cruzes - Sp, Brazil, 08780-090
      • Passo Fundo, Brazil, 99010-901
      • Porto Alegre, Brazil, 90035-001
      • Recife, Brazil, 50100-130
      • Sao Paulo, Brazil, 05403-000
      • Sao Paulo, Brazil, 01244-030
      • Sao Paulo, Brazil, 01221-020
      • Sao Paulo, Brazil, 04022-001
  • Canada
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
      • London, Ontario, Canada, N6A 5R8
      • Toronto, Ontario, Canada, M9W 4L6
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
      • Pointe-claire, Quebec, Canada, H9R 4S3
  • Costa Rica
      • San Jose, Costa Rica, 755-1000
  • France
      • Bondy, France, 93143
      • Dijon, France, 21079
      • Nantes, France, 44093
      • Narbonne, France, 11108
  • Germany
      • Falkensee, Germany, 14612
      • Karlsruhe, Germany, 76199
      • Mainz, Germany, 55116
      • Neuwied, Germany, 56564
      • Potsdam, Germany, 14469
  • Guatemala
      • Guatemala, Guatemala
      • Guatemala, Guatemala, 01010
  • Mexico
      • Chihuahua, Mexico, 31238
      • Jalisco, Mexico, 44690
      • Mexico City, Mexico, 11650
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
      • Guyanabo, San Juan, Puerto Rico, 00920
      • San Juan, Puerto Rico, 00926-2832
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Birmingham, Alabama, United States, 35209
      • Huntsville, Alabama, United States, 35801
      • Muscle Shoals, Alabama, United States, 35661
    • Arizona
      • Phoenix, Arizona, United States, 85032
      • Phoenix, Arizona, United States, 85028
    • California
      • Buena Park, California, United States, 90620
      • Lancaster, California, United States, 93534
      • Loma Linda, California, United States, 92354
      • Rancho Cucamonga, California, United States, 91730
      • Roseville, California, United States, 95661
      • San Diego, California, United States, 92161
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Wheatridge, Colorado, United States, 80033
    • Connecticut
      • Hamden, Connecticut, United States, 06518
    • District of Columbia
      • Washington, District of Columbia, United States, 20017
    • Florida
      • Bradenton, Florida, United States, 34208
      • Chiefland, Florida, United States, 32626
      • Fort Myers, Florida, United States, 33907
      • Gainesville, Florida, United States, 32607
      • Hollywood, Florida, United States, 33021
      • Miami, Florida, United States, 33136
      • New Port Richey, Florida, United States, 34652
      • Ocala, Florida, United States, 34474
      • Plantation, Florida, United States, 33317
      • Tampa, Florida, United States, 33614
    • Idaho
      • Nampa, Idaho, United States, 83687
    • Illinois
      • Aurora, Illinois, United States, 60504
      • Libertyville, Illinois, United States, 60048
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Iowa
      • Des Moines, Iowa, United States, 50314
    • Kansas
      • Topeka, Kansas, United States, 66614
    • Kentucky
      • Lexington, Kentucky, United States, 40504
      • Madisonville, Kentucky, United States, 42431
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Frederick, Maryland, United States, 21702
      • Oxon Hill, Maryland, United States, 20745
    • Michigan
      • Detroit, Michigan, United States, 48202
      • Ferndale, Michigan, United States, 48220
      • Kalamazoo, Michigan, United States, 49048
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
      • Olive Branch, Mississippi, United States, 38654
    • Missouri
      • St Peters, Missouri, United States, 63376
    • Nebraska
      • Omaha, Nebraska, United States, 68114
      • Omaha, Nebraska, United States, 68131
    • Nevada
      • Las Vegas, Nevada, United States, 89148
    • New York
      • Albany, New York, United States, 12206-1098
      • Brooklyn, New York, United States, 11218
      • Hudson, New York, United States, 12534
      • Lake Success, New York, United States, 11042
      • Staten Island, New York, United States, 10301
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
      • Charlotte, North Carolina, United States, 28262
      • Mooresville, North Carolina, United States, 28117
      • Wilmington, North Carolina, United States, 28401
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
    • Ohio
      • Athens, Ohio, United States, 45701
      • Cincinnati, Ohio, United States, 45219
      • Kettering, Ohio, United States, 45429
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
      • Bensalem, Pennsylvania, United States, 19020
      • Carlisle, Pennsylvania, United States, 17015
      • Levittown, Pennsylvania, United States, 19056
      • Melrose Park, Pennsylvania, United States, 19027
      • Pittsburgh, Pennsylvania, United States, 15236
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
    • South Carolina
      • Greer, South Carolina, United States, 29651
    • Texas
      • Bellaire, Texas, United States, 77401
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75230
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78205
    • Utah
      • Salt Lake City, Utah, United States, 84102
    • Washington
      • Federal Way, Washington, United States, 98003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-75 years age;
  • type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
  • HbA1c >=7.0% and <=10.0% at screening;
  • BMI >= 25 (>23 for Asians) and <=45 kg/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;
  • clinically symptomatic gastrointestinal disease;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
  • known hemoglobinopathy or chronic anemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo in addition to continued stable metformin plus pioglitazone treatment. 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.
Drug: metformin
>1500 mg/day or maximum tolerated dose (MTD)
Drug: pioglitazone
>= 30 mg/day
Drug: placebo
sc once weekly
Drug: taspoglutide
10 mg sc once weekly;
Drug: taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Experimental: Taspoglutide 10mg
Taspoglutide 10mg once weekly in addition to continued stable metformin plus pioglitazone treatment
Drug: metformin
>1500 mg/day or maximum tolerated dose (MTD)
Drug: pioglitazone
>= 30 mg/day
Drug: taspoglutide
10 mg sc once weekly;
Drug: taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Experimental: Taspoglutide 10mg/20mg
Taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued stable metformin plus pioglitazone treatment.
Drug: metformin
>1500 mg/day or maximum tolerated dose (MTD)
Drug: pioglitazone
>= 30 mg/day
Drug: taspoglutide
10 mg sc once weekly;
Drug: taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Absolute change from baseline in HbA1c
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; beta cell function.
Time Frame: 24 weeks
24 weeks
Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC20963
  • 2008-001744-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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