A Study of Taspoglutide in Type 2 Diabetic Patients
A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients
2 other identifiers
interventional
18
1 country
1
Brief Summary
This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes-mellitus-type-2
Started Nov 2008
Typical duration for phase_1 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedNovember 2, 2016
November 1, 2016
9 months
December 18, 2008
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incremental area under insulin concentration time curve relative to basal insulin concentration
First 10 minutes after glucose bolus
Secondary Outcomes (2)
Incremental area under insulin concentration time curve relative to basal insulin concentration
10-120 minutes after glucose bolus
Adverse events, laboratory parameters
Throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-65 years of age;
- type 2 diabetes mellitus;
- treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.
You may not qualify if:
- type 1 diabetes mellitus;
- type 2 diabetes duration of \<3 months;
- treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
- treatment with insulin for \>7 days within 6 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Neuss, 41460, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 19, 2008
Study Start
November 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
November 2, 2016
Record last verified: 2016-11