A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

November 1, 2016 updated by: Hoffmann-La Roche

Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1189

Phase

  • 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

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
      • Buenos Aires, Argentina, C1117ABH
      • Buenos Aires, Argentina, 6000
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
    • Queensland
      • Freemantle, Queensland, Australia, 6959
  • Brazil
    • GO
      • Goiania, GO, Brazil, 74043011
    • PA
      • Belem, PA, Brazil, 66073-000
    • PR
      • Curtiba, PR, Brazil, 80030-110
    • RS
      • Porto Alegre, RS, Brazil, 90035-170
    • SP
      • Mogi Das Cruzes - Sp, SP, Brazil, 08780-090
      • Sao Paulo, SP, Brazil, 01221-020
      • Sao Paulo, SP, Brazil, 04022-001
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
    • Ontario
      • London, Ontario, Canada, N6A 5R8
      • Toronto, Ontario, Canada, M5C 2T2
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 4S3
  • Denmark
      • Ballerup, Denmark, 2750
  • Finland
      • Helsinki, Finland, 00150
      • Kuopio, Finland, 70210
      • Oulu, Finland, 90100
      • Turku, Finland, 20100
  • France
      • Corbeil Essonnes, France, 91106
      • Dommartin Les Toul, France, 54200
      • Montpellier, France, 34295
      • Narbonne, France, 11108
      • Paris, France, 75475
      • Salouel, France, 80480
  • Germany
      • Aschaffenburg, Germany, 63739
      • Berlin, Germany, 10115
      • Damme, Germany, 49401
      • Dresden, Germany, 01219
      • Essen, Germany, 45359
      • Falkensee, Germany, 14612
      • Hamburg, Germany, 22607
      • Hamburg, Germany, 21073
      • Ludwigshafen, Germany, 67059
      • Mainz, Germany, 55116
      • München, Germany, 80634
      • Münster, Germany, 48145
      • Neuwied, Germany, 56564
      • Nürnberg, Germany, 90402
      • Pirna, Germany, 01796
      • Rhaunen, Germany, 55624
      • Villingen-Schwenningen, Germany, 78048
      • Zwenkau, Germany, 04442
  • Greece
      • Thessaloniki, Greece, 56429
      • Thessaloniki, Greece, 57010
  • Guatemala
      • Guatemala, Guatemala, 01014
      • Guatemala, Guatemala, 01000
  • Israel
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 31096
      • Holon, Israel, 58100
      • Jerusalem, Israel, 91200
      • Kfar Saba, Israel, 44281
      • Petach Tikva, Israel, 49100
      • Ramat Gan, Israel, 52621
      • Tel Aviv, Israel, 64239
  • Italy
    • Friuli-Venezia Giulia
      • Pordenone, Friuli-Venezia Giulia, Italy, 33170
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
    • Sardegna
      • Olbia, Sardegna, Italy, 07026
    • Toscana
      • Siena, Toscana, Italy, 53100
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of
  • Mexico
      • Acapulco, Mexico, 39670
      • Aguascalientes, Mexico, 20127
      • Chihuahua, Mexico, 31205
      • Durango, Mexico, 34000
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44600
      • Monterrey, Mexico, 64460
      • Monterrey, Mexico, 64700
      • Tampico, Mexico, 89000
  • New Zealand
      • Auckland, New Zealand
      • Auckland, New Zealand, 1640
  • Peru
      • Arequipa, Peru, Cercado
      • Lima, Peru, 41
      • Lima, Peru, Lima 33
  • Puerto Rico
      • Ponce, Puerto Rico, 00717-322
      • Ponce, Puerto Rico, 00716
  • Russian Federation
      • Barnaul, Russian Federation, 656024
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 125299
      • Moscow, Russian Federation, 109263
      • Moscow, Russian Federation, 119048
      • Moscow, Russian Federation, 125315
      • Moscow, Russian Federation, 119121
      • Moscow, Russian Federation, 121069
      • Nizhny Novgorod, Russian Federation, 603126
      • Novosibirsk, Russian Federation, 630047
      • Novosibirsk, Russian Federation, 630091
      • Omsk, Russian Federation, 644021
      • S. Petersburg, Russian Federation, 194291
      • S.Petersburg, Russian Federation, 194017
      • Saint-Petersburg, Russian Federation, 197022
      • Saratov, Russian Federation, 140018
      • St Petersburg, Russian Federation, 195213
      • St-Petersburg, Russian Federation, 194291
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 191124
      • St. Petersburg, Russian Federation, 193012
      • Tomsk, Russian Federation, 643050
      • Yaroslavl, Russian Federation, 150062
      • Yaroslavl, Russian Federation, 150010
  • South Africa
      • Cape Town, South Africa, 7130
      • Pretoria, South Africa, 0002
  • Spain
      • Almeria, Spain, 04001
      • Madrid, Spain, 28041
    • Alicante
      • Bacarot Alicant, Alicante, Spain, 03114
    • Valencia
      • Alzira, Valencia, Spain, 46600
  • Sweden
      • Karlstad, Sweden, 65185
      • Stockholm, Sweden, 171 76
      • Uppsala, Sweden, 75185
      • Örebro, Sweden, 701 85
  • Switzerland
      • Zürich, Switzerland, 8091
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
  • Ukraine
      • Dnipropetrovs'k, Ukraine, 49044
      • Donetsk, Ukraine, 83003
      • Kiev, Ukraine, 02091
      • Lviv, Ukraine, 79010
      • Odessa, Ukraine, 65009
      • Odessa, Ukraine, 65117
      • Simferopol, Ukraine, 95017
  • United Kingdom
      • Bath, United Kingdom, BA1 2SR
      • Bradford on Avon, United Kingdom, BA15 1DQ
      • Glasgow, United Kingdom, G45 9AW
      • Lanarkshire, United Kingdom, ML1 3JX
      • Trowbridge, United Kingdom, BA14 8QA
  • United States
    • Alabama
      • Haleyville, Alabama, United States, 35565
      • Mobile, Alabama, United States, 36617
      • Montgomery, Alabama, United States, 36106
      • Tuscaloosa, Alabama, United States, 35406
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
    • California
      • Escondido, California, United States, 92026
      • La Jolla, California, United States, 92037
      • Mission Viejo, California, United States, 92691
      • Orange, California, United States, 92868
      • Palm Springs, California, United States, 92262
      • Rancho Cucamonga, California, United States, 91730
      • Sacramento, California, United States, 95816-5119
      • San Leandro, California, United States, 94578
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
    • Florida
      • Daytona Beach, Florida, United States, 32114
      • Ft. Lauderdale, Florida, United States, 33316
      • Green Cove Springs, Florida, United States, 32043
      • Jacksonville, Florida, United States, 32216
      • Miami Beach, Florida, United States, 33140
      • Niceville, Florida, United States, 32578
      • Orlando, Florida, United States, 32804
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30318
      • Suwanee, Georgia, United States, 30024
    • Illinois
      • Chicago, Illinois, United States, 60607
      • Chicago, Illinois, United States, 60622
      • Lombard, Illinois, United States, 60148
      • Peoria, Illinois, United States, 61625
    • Indiana
      • Evansville, Indiana, United States, 47714
      • New Albany, Indiana, United States, 47150
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kentucky
      • Munfordville, Kentucky, United States, 42765
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Maine
      • Bangor, Maine, United States, 04401
    • Maryland
      • Baltimore, Maryland, United States, 21209
      • Bethesda, Maryland, United States, 20817
      • Rockville, Maryland, United States, 20854
    • Michigan
      • Royal Oak, Michigan, United States, 48073
    • Missouri
      • Jefferson City, Missouri, United States, 65109
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63117
      • Saint Louis, Missouri, United States, 63141
      • Washington, Missouri, United States, 63090
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
    • New Jersey
      • Trenton, New Jersey, United States, 08611
      • Voorhees, New Jersey, United States, 08043
      • Whitehouse, New Jersey, United States, 08889
    • New York
      • Brooklyn, New York, United States, 11203
      • New York, New York, United States, 10025
      • Rochester, New York, United States, 14607
      • Smithtown, New York, United States, 11787
      • Springfield Gardens, New York, United States, 11413
      • Staten Island, New York, United States, 10301
      • Syracuse, New York, United States, 13210
      • West Seneca, New York, United States, 14224
      • Westfield, New York, United States, 14787
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
      • Charlotte, North Carolina, United States, 28233
      • Durham, North Carolina, United States, 27713
      • Greensboro, North Carolina, United States, 27408
      • Hunters Ville, North Carolina, United States, 28078
      • Salisbury, North Carolina, United States, 28144
      • Winston-salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45236
      • Columbus, Ohio, United States, 43212
      • Westlake, Ohio, United States, 44145
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
      • Norristown, Pennsylvania, United States, 19401
      • Philadelphia, Pennsylvania, United States, 19107
      • Red Lion, Pennsylvania, United States, 17356
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
    • South Carolina
      • Clemson, South Carolina, United States, 29631
      • Columbia, South Carolina, United States, 29201
      • Hickory, South Carolina, United States, 28602
      • Simpsonville, South Carolina, United States, 29681
    • Tennessee
      • Bristol, Tennessee, United States, 37620
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75230
      • Houston, Texas, United States, 77024
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77005
    • Virginia
      • Richmond, Virginia, United States, 23226
    • Washington
      • Everett, Washington, United States, 98201

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

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 of age;
  • type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
  • HbA1c >=7.0% and <=10% at screening;
  • BMI >=25kg/m2 (>23kg/m2 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, diabetes resulting from pancreatic injury or secondary forms of diabetes;
  • history of acute metabolic diabetic complications within the previous 6 months;
  • evidence of clinically significant diabetic complications;
  • known proliferative diabetic retinopathy;
  • myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
  • any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
  • known hemoglobinopathy or chronic anemia;
  • clinically significant gastrointestinal disease.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: exenatide
Drug: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily
Experimental: taspoglutide 10mg
Drug: taspoglutide
10mg once weekly
Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
Experimental: taspoglutide 10mg/20mg
Drug: taspoglutide
10mg once weekly
Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting body weight
Time Frame: 24 weeks
24 weeks
Proportion of patients reaching target HbA1c <=7.0%, <=6.5%
Time Frame: 24 weeks
24 weeks
Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients.
Time Frame: 24 weeks
24 weeks
Beta cell function (proinsulin/insulin ratio)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (Estimate)

July 17, 2008

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC21625
  • 2008-001856-36

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.

Clinical Trials on Diabetes Mellitus Type 2

Clinical Trials on exenatide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe