A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

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Roche

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: placebo
Drug: taspoglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00823992
2008-005809-20
BC22092

Details and patient eligibility

About

This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Enrollment

305 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus, receiving metformin at a stable dose of >=1500mg/day for at least 12 weeks;
  • HbA1c >=6.5% and <=9.5% at screening;
  • BMI >=30 and <=50 kg/m2 at screening;
  • stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion criteria

  • history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
  • evidence of clinically significant diabetic complications;
  • myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

305 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Treatment:
Drug: placebo
taspoglutide
Experimental group
Treatment:
Drug: taspoglutide

Trial contacts and locations

71

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Data sourced from clinicaltrials.gov

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