| Trial ID: | L5368 |
| Source ID: | NCT00971659
|
| Associated Drug: |
Insulin Glargine + Exenatide + Preexisting Metformin
|
| Title: |
Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: insulin glargine + exenatide + preexisting metformin|DRUG: insulin glargine + sitagliptin + preexisting metformin|DRUG: insulin glargine + preexisting metformin
|
| Outcome Measures: |
Primary: the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast, after 4 weeks of treatment | Secondary: mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes, after 4 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Profil Institut für Stoffwechselforschung GmbH | Collaborators: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01
|
| Completion Date: |
2008-11
|
| Results First Posted: |
|
| Last Update Posted: |
2009-09-04
|
| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00971659
|
