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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717457
First received: July 16, 2008
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 3-arm study will assess the efficacy, safety and tolerability of taspogluti de compared with exenatide in patients with type 2 diabetes mellitus inadequatel y controlled with metformin, thiazolidinedione or a combination of both. Patient s will be randomized to receive taspoglutide (10mg once weekly or 10mg once week ly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice da ily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in ad dition 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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: exenatide
Drug: taspoglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients reaching target HbA1c <=7.0%, <=6.5% [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Beta cell function (proinsulin/insulin ratio) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1189
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10mg once weekly
Experimental: 2 Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly
Active Comparator: 3 Drug: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00717457

  Hide Study Locations
Locations
United States, Alabama
Haleyville, Alabama, United States, 35565
Mobile, Alabama, United States, 36617
Montgomery, Alabama, United States, 36106
Tuscaloosa, Alabama, United States, 35406
United States, Arkansas
Little Rock, Arkansas, United States, 72204
United States, 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
United States, Colorado
Colorado Springs, Colorado, United States, 80904
United States, 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
United States, Georgia
Atlanta, Georgia, United States, 30318
Atlanta, Georgia, United States, 30308
Suwanee, Georgia, United States, 30024
United States, Illinois
Chicago, Illinois, United States, 60622
Chicago, Illinois, United States, 60607
Lombard, Illinois, United States, 60148
Peoria, Illinois, United States, 61625
United States, Indiana
Evansville, Indiana, United States, 47714
New Albany, Indiana, United States, 47150
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Munfordville, Kentucky, United States, 42765
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Maine
Bangor, Maine, United States, 04401
United States, Maryland
Baltimore, Maryland, United States, 21209
Bethesda, Maryland, United States, 20817
Rockville, Maryland, United States, 20854
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Missouri
Jefferson City, Missouri, United States, 65109
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63141
Saint Louis, Missouri, United States, 63117
Washington, Missouri, United States, 63090
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Concord, New Hampshire, United States, 03301
United States, New Jersey
Trenton, New Jersey, United States, 08611
Voorhees, New Jersey, United States, 08043
Whitehouse, New Jersey, United States, 08889
United States, 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
United States, 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
United States, North Dakota
Fargo, North Dakota, United States, 58103
United States, Ohio
Cincinnati, Ohio, United States, 45236
Columbus, Ohio, United States, 43212
Westlake, Ohio, United States, 44145
United States, Oregon
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97239
United States, Pennsylvania
Altoona, Pennsylvania, United States, 16602
Norristown, Pennsylvania, United States, 19401
Philadelphia, Pennsylvania, United States, 19107
Red Lion, Pennsylvania, United States, 17356
United States, Rhode Island
Providence, Rhode Island, United States, 02908
United States, 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
United States, Tennessee
Bristol, Tennessee, United States, 37620
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77005
Houston, Texas, United States, 77024
Houston, Texas, United States, 77074
United States, Virginia
Richmond, Virginia, United States, 23226
United States, Washington
Everett, Washington, United States, 98201
Argentina
Buenos Aires, Argentina, C1117ABH
Buenos Aires, Argentina, 6000
Buenos Aires, Argentina, C1181ACH
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Freemantle, Queensland, Australia, 6959
Brazil
Goiania, GO, Brazil, 74043011
Belem, PA, Brazil, 66073-000
Curtiba, PR, Brazil, 80030-110
Porto Alegre, RS, Brazil, 90035-170
Mogi Das Cruzes - Sp, SP, Brazil, 08780-090
Sao Paulo, SP, Brazil, 04022-001
Sao Paulo, SP, Brazil, 01221-020
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
London, Ontario, Canada, N6A 5R8
Toronto, Ontario, Canada, M5C 2T2
Canada, 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, 21073
Hamburg, Germany, 22607
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
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Genova, Liguria, Italy, 16132
Pavia, Lombardia, Italy, 27100
Olbia, Sardegna, Italy, 07026
Siena, Toscana, Italy, 53100
Korea, Republic of
Seoul, Korea, Republic of, 0
Seoul, Korea, Republic of, 110-744
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, 1640
Auckland, New Zealand
Peru
Arequipa, Peru, Cercado
Lima, Peru, 41
Lima, Peru, Lima 33
Puerto Rico
Ponce, Puerto Rico, 00716
Ponce, Puerto Rico, 00717-322
Russian Federation
Barnaul, Russian Federation, 656024
Moscow, Russian Federation, 121069
Moscow, Russian Federation, 119121
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 125299
Moscow, Russian Federation, 119048
Moscow, Russian Federation, 109263
Moscow, Russian Federation, 125315
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk, Russian Federation, 630091
Novosibirsk, Russian Federation, 630047
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, 193012
St. Petersburg, Russian Federation, 191124
St. Petersburg, Russian Federation, 194354
Tomsk, Russian Federation, 643050
Yaroslavl, Russian Federation, 150062
Yaroslavl, Russian Federation, 150010
South Africa
Cape Town, South Africa, 7130
Pretoria, South Africa, 0002
Spain
Bacarot Alicant, Alicante, Spain, 03114
Alzira, Valencia, Spain, 46600
Almeria, Spain, 04001
Madrid, Spain, 28041
Sweden
Karlstad, Sweden, 65185
Stockholm, Sweden, 171 76
Uppsala, Sweden, 75185
Örebro, Sweden, 701 85
Switzerland
Zürich, Switzerland, 8091
Thailand
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Ukraine
Dnipropetrovs'k, Ukraine, 49044
Donetsk, Ukraine, 83003
Kiev, Ukraine, 02091
Lviv, Ukraine, 79010
Odessa, Ukraine, 65117
Odessa, Ukraine, 65009
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717457     History of Changes
Other Study ID Numbers: BC21625, 2008-001856-36
Study First Received: July 16, 2008
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014