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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01489644
• Collaborator: (none)
• Enrollment: 62
• Locations: 2
• Arms: 4
• Duration (Days): 30
• Patients Per Site: 31
• Patients Per Site Per Month: 31.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: repaglinide; Drug: metformin; Drug: repaglinide and metformin combination tablet	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single-Blind, Four-Period Crossover Study Examining the Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet Dosing (NN4440) in Fasting and Fed Healthy Volunteers
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment period 1	Drug: repaglinide; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: metformin; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: repaglinide and metformin combination tablet; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
Experimental: Treatment period 2	Drug: repaglinide; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: metformin; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: repaglinide and metformin combination tablet; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
Experimental: Treatment period 3	Drug: repaglinide; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: metformin; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: repaglinide and metformin combination tablet; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
Active Comparator: Treatment period 4	Drug: repaglinide; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: metformin; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order; Drug: repaglinide and metformin combination tablet; Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order

Outcome Measures

Primary Outcome Measures

1. Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration []

2. Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration []

3. Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration []

4. Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration []

Secondary Outcome Measures

1. Repaglinide and metformin tmax (time to maximum) following individual administration fasting state []

2. Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state []

3. Physical examinations []

4. Vital signs []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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, health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product 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 administration

• Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Miami	Florida	United States	33169
2	Novo Nordisk Investigational Site	Tacoma	Washington	United States	98418

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01489644
• Other Study ID Numbers: NN4440-1779
• First Posted: Dec 9, 2011
• Last Update Posted: Feb 10, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Repaglinide

Study Results

No Results Posted as of Feb 10, 2017