Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01490658
First received: December 8, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide
Drug: metformin
Drug: repaglinide and metformin combination tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blind, Three-Period Crossover Study Examining the Single Dose Pharmacokinetics of Concomitantly Administered Repaglinide and Metformin Versus Combination Tablet Dosing (NN4440) in Fed Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration [ Designated as safety issue: No ]
  • Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet [ Designated as safety issue: No ]
  • Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration [ Designated as safety issue: No ]
  • NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Repaglinide AUC after NN4440 (1/500) during fed state [ Designated as safety issue: No ]
  • Repaglinide Cmax after NN4440 ((1/500) during fed state [ Designated as safety issue: No ]
  • Change in physical examinations from screening [ Designated as safety issue: No ]
  • Vital signs [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: June 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment period 1 Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Experimental: Treatment period 2 Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Active Comparator: Treatment period 3 Drug: repaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: metformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Drug: repaglinide and metformin combination tablet
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
  • BMI (Body Mass Index) between 19-29 kg/m^2, both inclusive
  • Fasting plasma glucose from 70-115 mg/dl
  • Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion Criteria:

  • Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
  • Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
  • Positive results on screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody
  • Positive results on the drug abuse/alcohol screen
  • Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose administration) and for the duration of the study
  • Subject is currently a smoker (more than one cigarette per day or equivalent)
  • Use of grapefruit or grapefruit juice within 7 days of trial product dose administration
  • Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490658

Locations
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78744
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: William Lyness, Ph.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01490658     History of Changes
Other Study ID Numbers: NN4440-1753
Study First Received: December 8, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Repaglinide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014