We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Food Effect on the Pharmacokinetics of Sustained Release Metformin in Healthy Indian Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561976
First Posted: March 23, 2012
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Metformin hydrochloride prolonged release
Drug: metformin hydrochloride prolonged release
Drug: Metformin hydrochloride sustained release/Glimepiride

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted at one center in India from 30 January 2012 to 21 February 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 30 participants were enrolled in this study. METLEAD™ Forte SR (metformin hydrochloride prolonged release) and METLEAD™ G2 Forte (metformin hydrochloride sustained release/glimepiride) are registered product of GlaxoSmithKline.

Reporting Groups
  Description
METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting In this sequence participants received single oral dose of METLEAD G2 Forte 1000 milligrams (mg)/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1 (day after the dosing day), breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post dose respectively.
METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.

Participant Flow for 5 periods

Period 1:   Period 1
    METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte   METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed   METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte   METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
STARTED   5   5   5   5   5   5 
COMPLETED   5   5   4   5   5   5 
NOT COMPLETED   0   0   1   0   0   0 
Adverse Event                0                0                1                0                0                0 

Period 2:   Washout Period 1 (7 Days)
    METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte   METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed   METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte   METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
STARTED   5   5   4   5   5   5 
COMPLETED   5   5   4   4   5   4 
NOT COMPLETED   0   0   0   1   0   1 
Adverse Event                0                0                0                1                0                0 
Withdrawal by Subject                0                0                0                0                0                1 

Period 3:   Period 2
    METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte   METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed   METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte   METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
STARTED   5   5   4   4   5   4 
COMPLETED   5   5   4   4   5   4 
NOT COMPLETED   0   0   0   0   0   0 

Period 4:   Washout Period 2 (7 Days)
    METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte   METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed   METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte   METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
STARTED   5   5   4   4   5   4 
COMPLETED   4   5   3   4   5   4 
NOT COMPLETED   1   0   1   0   0   0 
Non-compliance                1                0                1                0                0                0 

Period 5:   Period 3
    METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte   METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed   METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte   METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed
STARTED   4   5   3   4   5   4 
COMPLETED   4   5   3   4   5   4 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. Dosing was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD ForteSR 1000 mg tablet in fed state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fasting state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fasting state in period 1, METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte In this sequence participants received single oral dose of METLEAD ForteSR 1000 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed In this sequence participants received single oral dose of METLEAD G2 Forte 1000 mg/2 mg tablet in fed state in period 1, METLEAD ForteSR 1000 mg tablet in fasting state in period 2 and METLEAD ForteSR 1000 mg tablet in fed state in period 3. There was a washout period of 7 days between each treatment period. In the fasting and fed conditions, the pre-dose dinner was administered 11 hours prior to dosing. In fasting condition, dosing took place at the scheduled time followed by breakfast, lunch and dinner at 4, 8 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively. In the fed condition, breakfast was served at the scheduled time. The dosing of drug was at the same scheduled time as dosing in the fasting condition. Lunch, snack and dinner was served at 4, 9 and 13 hours post-dose respectively. On D+1, breakfast and lunch was provided at 25 hours and 30 hours post-dose respectively.
Total Total of all reporting groups

Baseline Measures
   METLEAD G2 Forte, METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed, METLEAD G2 Forte   METLEAD ForteSR-Fed, METLEAD G2 Forte, METLEAD ForteSR-Fasting   METLEAD ForteSR-Fasting, METLEAD G2 Forte, METLEAD ForteSR-Fed   METLEAD ForteSR-Fed, METLEAD ForteSR-Fasting, METLEAD G2 Forte   METLEAD G2 Forte, METLEAD ForteSR-Fasting, METLEAD ForteSR-Fed   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   5   5   5   5   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.2  (5.63)   25.6  (4.72)   27.0  (5.79)   31.8  (9.31)   34.6  (6.73)   25.4  (3.78)   28.8  (6.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      5 100.0%      5 100.0%      5 100.0%      5 100.0%      5 100.0%      5 100.0%      30 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
             
India   5   5   5   5   5   5   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Observed Concentration (Cmax)   [ Time Frame: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing ]

2.  Primary:   Area Under Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC (0-infinity)]   [ Time Frame: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing ]

3.  Secondary:   AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC (0-t)]   [ Time Frame: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing ]

4.  Secondary:   Time of Occurrence of Cmax (Tmax)   [ Time Frame: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing ]

5.  Secondary:   PK Lag Time (Tlag)   [ Time Frame: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing ]

6.  Secondary:   Elimination Constant (Kel)   [ Time Frame: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing ]

7.  Secondary:   Terminal Phase Half Life (t1/2)   [ Time Frame: 0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing ]

8.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to approximately 24 days (during treatment and washout) after initiation of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
LIESEL DSILVA, JONATHAN PALMER, VISHWANATH SUDERSHAN, SANMAN GHORPADE, SADHNA JOGLEKAR . Effect of food on the absorption of metformin from sustained release metformin hydrochloride formulations in healthy Indian volunteers. Asian J Pharmaceut Clin Res. 2013;6(1):95-99.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01561976     History of Changes
Other Study ID Numbers: 116519
First Submitted: February 16, 2012
First Posted: March 23, 2012
Results First Submitted: August 10, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017