Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

NCT01517373 | Completed Phase 2 Results DMC

• 2 other identifiers: B16210022011-005206-30
• Study Type: interventional
• Target: 304
• Locations: 7 countries
• Sites: 53

Brief Summary

This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin

Conditions

Diabetes Mellitus, Type 2

Keywords

T2DM; PF-04937319; Phase 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12

  HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.

  Baseline (Day 1), Week 12

Secondary Outcomes (11)

• Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8

  Baseline (Day 1), Week 2, 4, 6, 8

• Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12

  Baseline (Day 1), Week 2, 4, 6, 8, 12

• Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12

  Week 12

• Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data

  Baseline (Day 1) up to Week 14

• Number of Participants With Increase/Decrease From Baseline Vital Signs Data

  Baseline (Day 1) up to Week 14

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo to match PF-04937319 and glimepiride

Drug: Placebo

PF-04937319 10 mg

EXPERIMENTAL

Drug: PF-04937319 10 mg

PF-04937319 50 mg

EXPERIMENTAL

Drug: PF-04937319 50 mg

PF-04937319 100 mg

EXPERIMENTAL

Drug: PF-04937319 100 mg

Glimepiride

ACTIVE COMPARATOR

Drug: Glimepiride

Interventions

Placebo DRUG

Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days

Placebo

PF-04937319 10 mg DRUG

Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days

PF-04937319 10 mg

PF-04937319 50 mg DRUG

Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days

PF-04937319 50 mg

PF-04937319 100 mg DRUG

Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days

PF-04937319 100 mg

Glimepiride DRUG

Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days

Glimepiride

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

You may not qualify if:

• Subjects with recent cardiovascular events, those with evidence of diabetic complications

Sponsors & Collaborators

• Pfizer: lead

Study Sites (53)

Sierra Clinical Research

Roseville, California, 95661, United States

Location

California Research Foundation

San Diego, California, 92103, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

South Broward Research, LLC

Pembroke Pines, Florida, 33027, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Clinical Research Center of Cape Cod, Inc.

Hyannis, Massachusetts, 02601, United States

Location

Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, 28557, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45246, United States

Location

Community Research

Cincinnati, Ohio, 45255, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Holston Medical Group

Bristol, Tennessee, 37620, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Diagnostic Center

Chattanooga, Tennessee, 37404, United States

Location

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Bristol Clinical Research, LLC

Austin, Texas, 78728, United States

Location

DiscoveResearch, Inc.

Bryan, Texas, 77802, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, 75230, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

National Clinical Research - Norfolk, Inc.

Norfolk, Virginia, 23502, United States

Location

National Clinical Research - Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Aurora Advanced Healthcare, Inc.

Milwaukee, Wisconsin, 53209, United States

Location

MBAL Yulia Vrevska - Byala, Otdelenie po vatreshni bolesti

Byala, 7100, Bulgaria

Location

MBAL - Ruse AD, Vtoro otdelenie po vatreshni bolesti

Rousse, 7002, Bulgaria

Location

DKTs Akta Medika, Kabinet po endokrinologia

Sevlievo, 5400, Bulgaria

Location

UMBAL Aleksandrovska, Klinika po endokrinologia i bolesti na obmyanata

Sofia, 1431, Bulgaria

Location

VMA - MBAL - Sofia, Klinika po endokrinologia i bolesti na obmyanata

Sofia, 1606, Bulgaria

Location

UMBAL Stara Zagora, Klinika po endokrinologia i bolesti na obmyanata

Stara Zagora, 6003, Bulgaria

Location

Glover Medical Clinic

Langley, British Columbia, V3A 4H9, Canada

Location

Ocean West Research Clinic Inc.

Surrey, British Columbia, V3S 2N6, Canada

Location

Rivergrove Medical Clinic

Winnipeg, Manitoba, R2V 4W3, Canada

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

DCTM CLinical Trials Group Ltd.

Strathroy, Ontario, N7G 1Y7, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Alpha Recherche Clinique

Québec, Quebec, G3K 2P8, Canada

Location

Pro-Recherche

Saint Romuald, Quebec, G6W 5M6, Canada

Location

Centre de cardiologie et de Recherche Clinique Pierre-Le Gardeur

Terrebonne, Quebec, J6V 1S8, Canada

Location

Dr. Kenessey Albert Korhaz-Rendelointezet/Belgyogyaszat

Balassagyarmat, 2660, Hungary

Location

Synexus Magyarorszag Kft.

Budapest, 1036, Hungary

Location

Semmelweis Egyetem/I. sz. Belgyogyaszati Klinika

Budapest, 1083, Hungary

Location

Fejer Megyei Szent Gyorgy Korhaz/II. Belgyogyaszati Osztaly

Székesfehérvár, 8000, Hungary

Location

BGS Global Hospital

Bangalore, Karnataka, 560060, India

Location

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, 411 004, India

Location

Diabetes Unit, K.E.M. Hospital Research Centre

Pune, Maharashtra, 411 011, India

Location

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

Banská Bystrica, 975 17, Slovakia

Location

Interna A Diabetologicka Ambulancia

Moldava nad Bodvou, 045 01, Slovakia

Location

FUNKYSTUFF, s.r.o.

Nové Zámky, 940 01, Slovakia

Location

MEDIAB, s.r.o.

Pezinok, 902 01, Slovakia

Location

MEDIVASA, s.r.o.

Žilina, 010 01, Slovakia

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Related Publications (1)

• Amin NB, Aggarwal N, Pall D, Paragh G, Denney WS, Le V, Riggs M, Calle RA. Two dose-ranging studies with PF-04937319, a systemic partial activator of glucokinase, as add-on therapy to metformin in adults with type 2 diabetes. Diabetes Obes Metab. 2015 Aug;17(8):751-9. doi: 10.1111/dom.12474. Epub 2015 May 11.

  PMID: 25885172 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

N,N-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Locations

CA (9); US (23); IN (3); HU (4); SL (5); TW (3); BU (6)