Drug Interaction of Vildagliptin (LAF237) With Voglibose in Japanese Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01309698
First received: March 4, 2011
Last updated: October 10, 2011
Last verified: October 2011
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Purpose
This study will evaluate the effect of voglibose on the pharmacokinetics and pharmacodynamics of vildagliptin in Japanese patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open-label, Randomized and Crossover Study to Assess the Effect of Co-administration of Vildagliptin and Voglibose on the Steady-state Pharmacokinetics / Pharmacodynamics in Japanese Patients With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Pharmacokinetics of vildagliptin [ Time Frame: Up to 12 hours post-dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacodynamic parameters (dipeptidyl peptidase IV (DPP-4) activity, glucagon-like peptide-1(GLP-1), glucose, insulin, glucagon) [ Time Frame: Up to 4 hours or 12 hours post-dose ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | February 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment Sequence 1 | Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose |
| Experimental: Treatment Sequence 2 | Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose |
| Experimental: Treatment Sequence 3 | Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose |
| Experimental: Treatment Sequence 4 | Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose |
| Experimental: Treatment Sequence 5 | Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose |
| Experimental: Treatment Sequence 6 | Drug: Vildagliptin (LAF237) Drug: Voglibose Drug: Vildagliptin and Voglibose |
Eligibility| Ages Eligible for Study: | 20 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diabetic patients with inadequately controlled on diet therapy and exercise therapy (HbA1c in the range 6.5 to 10.0% inclusive by NGSP)
Exclusion Criteria:
- Fasting plasma glucose ≥ 270 mg/dL A history of Type 1 diabetes or secondary forms of diabetes Treatment of anti-diabetic agents including GLP-1 analogues within 8 weeks or insulin within 6 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01309698 History of Changes |
| Other Study ID Numbers: | CLAF237A1103 |
| Study First Received: | March 4, 2011 |
| Last Updated: | October 10, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Novartis:
|
Drug interaction |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Voglibose Vildagliptin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013