Clinical trial NCT01517373: Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
Official title: A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Glimepiride In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: T2DM
PF-04937319
Phase 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12
timeFrame: Baseline (Day 1), Week 12
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8
timeFrame: Baseline (Day 1), Week 2, 4, 6, 8
measure: Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12
timeFrame: Baseline (Day 1), Week 2, 4, 6, 8, 12
measure: Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12
timeFrame: Week 12
measure: Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data
timeFrame: Baseline (Day 1) up to Week 14
measure: Number of Participants With Increase/Decrease From Baseline Vital Signs Data
timeFrame: Baseline (Day 1) up to Week 14
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)
measure: Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode
timeFrame: Baseline (Day 1) up to Week 14
measure: Number of Hypoglycemic Events (HAE) Episodes Per Participant
timeFrame: Baseline (Day 1) up to Week 14
measure: Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant
timeFrame: Baseline (Day 1) up to Week 14
measure: Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14
timeFrame: Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Baseline (Day 1) up to Week 14
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Sierra Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research, LLC
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Hyannis
country: United States
facility: Clinical Research Center of Cape Cod, Inc.
state: Massachusetts
city: Morehead City
country: United States
facility: Diabetes & Endocrinology Consultants, PC
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Medical Research, LLC
state: Tennessee
city: Chattanooga
country: United States
facility: Diagnostic Center
state: Tennessee
city: Chattanooga
country: United States
facility: University Diabetes and Endocrine Consultants
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Bristol Clinical Research, LLC
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc.
state: Wisconsin
city: Byala
country: Bulgaria
facility: MBAL Yulia Vrevska - Byala, Otdelenie po vatreshni bolesti
city: Ruse
country: Bulgaria
facility: MBAL - Ruse AD, Vtoro otdelenie po vatreshni bolesti
city: Sevlievo
country: Bulgaria
facility: DKTs Akta Medika, Kabinet po endokrinologia
city: Sofia
country: Bulgaria
facility: UMBAL Aleksandrovska, Klinika po endokrinologia i bolesti na obmyanata
city: Sofia
country: Bulgaria
facility: VMA - MBAL - Sofia, Klinika po endokrinologia i bolesti na obmyanata
city: Stara Zagora
country: Bulgaria
facility: UMBAL Stara Zagora, Klinika po endokrinologia i bolesti na obmyanata
city: Langley
country: Canada
facility: Glover Medical Clinic
state: British Columbia
city: Surrey
country: Canada
facility: Ocean West Research Clinic Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Rivergrove Medical Clinic
state: Manitoba
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Strathroy
country: Canada
facility: DCTM CLinical Trials Group Ltd.
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: St-Romuald
country: Canada
facility: Pro-Recherche
state: Quebec
city: Terrebonne
country: Canada
facility: Centre de cardiologie et de Recherche Clinique Pierre-Le Gardeur
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz-Rendelointezet/Belgyogyaszat
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem/I. sz. Belgyogyaszati Klinika
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz/II. Belgyogyaszati Osztaly
city: Bangalore
country: India
facility: BGS Global Hospital
state: Karnataka
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Diabetes Unit, K.E.M. Hospital Research Centre
state: Maharashtra
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
city: Moldava Nad Bodvou
country: Slovakia
facility: Interna A Diabetologicka Ambulancia
city: Nove Zamky
country: Slovakia
facility: FUNKYSTUFF, s.r.o.
city: Pezinok
country: Slovakia
facility: MEDIAB, s.r.o.
city: Zilina
country: Slovakia
facility: MEDIVASA, s.r.o.
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.