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Clinical Trial to Evaluate Safety of Metformin Glycinate in Healthy Volunteers (NTC00940472)

This study is currently recruiting participants.
Verified March 2012 by Laboratorios Silanes S.A. de C.V.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01560481
First received: February 9, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

Glycinate of metformin is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Glycinate of metformin was found to improve metabolic control without inducing a modification in insulin sensitivity in naive patients with type 2 diabetes.

The objective is to evaluate safety and tolerability profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers.

In step B the objective is to evaluate Safety and tolerability of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.


Condition Intervention Phase
Human Volunteers
 Drug: Step A: metformin glycinate 620 mg single dose
Drug: Step A: metformin glycinate 1240 mg single dose
Drug: Step A: metformin glycinate 2480 mg single dose
Drug: Step A: metformin Chlorhydrate 1000 mg single dose
Drug: Step A: metformin glycinate 1240 mg, intake of food
Drug: Step B: metformin glycinate 620 mg BID
Drug: Step B: metformin Chlorhydrate 500 mg BID
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Cross Over Randomized Clinical Trial to Evaluate Tolerability and Pharmacodynamic Profile of Metformin Glycinate 620 mg, Metformin Glycinate 1240 mg, Metformin Glycinate 2480 mg and Metformin Chlorhydrate 1000 mg After Administration of One Single Dose, Multiple Dose and Intake of Food in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

    Tolerability:

    • adverse events,
    • systolic and diastolic blood pressure, pulse rate and temperature
    • pulse rate and ECG alterations
    • alterations in haematology, plasma chemistry, and urine analyses

  • Step B: Number of Adverse Events of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]

    Tolerability:

    • adverse events,
    • systolic and diastolic blood pressure, pulse rate and temperature
    • pulse rate and ECG alterations
    • alterations in haematology, plasma chemistry, and urine analyses


Secondary Outcome Measures:
  • Step A: Bioavailability (AUC) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step A: Linear and dose-proportional (AUC) pharmacokinetic of 620 mg, 1240 mg and 2480 strengths of metformin glycinate [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step A: Bioavailability (AUC) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step A: Pharmacokinetic profile (AUC) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step B: Bioavailability (AUC) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Step B: Pharmacokinetic profile (AUC) of metformin glycinate 620mg BID after administration of multiple doses during 8 days [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Step A: Bioavailability (Cmax) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step A: Linear and dose-proportional pharmacokinetic (Cmax) of 620 mg, 1240 mg and 2480 strengths of metformin glycinate [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step A: Bioavailability (Cmax) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step A: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD. [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Step B: Bioavailability (Cmax) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days. [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Step B: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg BID after administration of multiple doses during 8 days [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Step A: metformin glycinate 620 mg Drug: Step A: metformin glycinate 620 mg single dose
metformin glycinate 620 mg single dose
Experimental: Step A: metformin glycinate 1240 mg Drug: Step A: metformin glycinate 1240 mg single dose
metformin glycinate 1240 mg single dose
Experimental: Step A: metformin glycinate 2480 mg Drug: Step A: metformin glycinate 2480 mg single dose
metformin glycinate 2480 mg single dose
Active Comparator: Step A: metformin Chlorhydrate 1000 mg Drug: Step A: metformin Chlorhydrate 1000 mg single dose
metformin Chlorhydrate 1000 mg single dose
Experimental: Step A: metformin glycinate 1240 mg, intake of food Drug: Step A: metformin glycinate 1240 mg, intake of food
metformin glycinate 1240 mg, intake of food
Experimental: Step B: metformin glycinate 620 mg BID Drug: Step B: metformin glycinate 620 mg BID
metformin glycinate 620 mg BID, 8 days
Active Comparator: Step B: metformin Chlorhydrate 500 mg BID Drug: Step B: metformin Chlorhydrate 500 mg BID
metformin Chlorhydrate 500 mg BID, 8 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 45 years.
  • Weight within normal ranges (Quetelet index between 21 and 26) (weight (kg)/height (m2).
  • Adequate physical examination and clinical history
  • No organic and psychiatric disorder
  • Normal Blood pressure, Pulse Rate, temperature and ECG.
  • Lab test within normal values according to reference lab values of Biochemistry lab of Hospital Santa Creu I Sant Pau. It will be allowed changes according to clinical criteria of the clinical staff of ICIM-SANT PAU
  • Females of childbearing potential with adequate contraceptive precautions, other than oral contraceptives and negative urine pregnancy test.
  • No participation in any other clinical trial within the previous two months before the initiation of this study.
  • No blood donation within the previous four weeks before the initiation of this study.
  • Signed informed consent.

Exclusion Criteria:

  • Drugs or alcohol abuse.
  • Consumer of stimulant drinks (> 5 coffees, teas, cola drinks).
  • Smokers (> 10 cigars).
  • Precedents of drugs allergy or hypersensitivity
  • Intake of any other medication within the previous 15 days before this study.
  • Positive HIV, HBV or HCV.
  • Chronic disease (cardiovascular, respiratory, endocrine, gastrointestinal, hematologic, neurologic or others).
  • Prior surgery within the previous six months before the initiation of this study.
  • Pregnant women or breastfeeding or females of childbearing potential with no adequate contraceptive precautions, other than oral contraceptives.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560481

Contacts
Contact: Rosa M Antonijoan, MD + 34 93 2919019 rantonijoana@santpau.cat
Contact: Montserrat Puntes, MD + 34 93 2919019 mpuntes@santpau.cat

Locations
Spain
Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Rosa M Antonijoan, MD     +3493 2919019     rantonijoana@santpau.cat    
Contact: Montserrat Puntes, MD     +3493 2919019     mpuntes@santpau.cat    
Principal Investigator: Rosa M Antonijoan, MD            
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
Study Chair: Rosa M Antonijoan, MD Centre d'Investigació de Medicaments Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01560481     History of Changes
Other Study ID Numbers: NTC00940472
Study First Received: February 9, 2012
Last Updated: March 20, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Laboratorios Silanes S.A. de C.V.:
Human Volunteers

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013