Clinical trial NCT01475461: Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes
Official title: A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety And Efficacy Of Pf-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 2
type 2 diabetes mellitus
PF-04937319
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion Criteria:

* patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening

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 and 8
timeFrame: Baseline(Day 1), Week 2, 4, 8
measure: Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14
timeFrame: Baseline (Day 1), Week 1, 2, 4, 8, 12, 14
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 (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: Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14
timeFrame: Baseline (Day 1), Week 2, 4, 8 , 12 , 14
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Baseline (Day 1) up to Week 14
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Belleview
country: United States
facility: The Family Doctors of Belleview
state: Florida
city: Miami
country: United States
facility: Swiss Medical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Conyers
country: United States
facility: Rockdale Medical Research Associates
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Mount Sterling
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Mount Sterling
country: United States
facility: Mount Sterling Clinic
state: Kentucky
city: Las Vegas
country: United States
facility: The Office of Dr. Matthew S. Barton, MD
state: Nevada
city: Paramus
country: United States
facility: TKL Research, Inc.
state: New Jersey
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Kettering
country: United States
facility: PriMed Clinical Research
state: Ohio
city: Kettering
country: United States
facility: PriMed Physicians
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Charleston
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Charleston
country: United States
facility: Newton Family Medicine
state: South Carolina
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Plano
country: United States
facility: Plano Primary Care Clinic
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Balatonfured
country: Hungary
facility: DRC Kft.
city: Bekescsaba
country: Hungary
facility: Dr. Rethy Pal Korhaz-Rendelointezet
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Debrecen
country: Hungary
facility: Kenezy Korhaz Rendelointezet Egeszsegugyi Nonprofit Kft.
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Polgar
country: Hungary
facility: Polgar es Tersege Egeszsegugyi Kozpont Nonprofit Zrt.
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz
city: Mumbai
country: India
facility: Bhatia Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Seth G S Medical College & KEM Hospital, Dept of Endocrinology,
state: Maharashtra
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd.
state: Maharashtra
city: Jaipur
country: India
facility: S.R. Kalla Memorial Gastro and General Hospital
state: Rajasthan
city: Cebu City
country: Philippines
facility: Vicente Sotto Memorial Medical Center
city: Marikina City
country: Philippines
facility: Institute for Studies on Diabetes Foundation Inc.
city: Pasig City
country: Philippines
facility: The Medical City
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca
state: Jud. Cluj
city: Bucuresti
country: Romania
facility: Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
city: Bucuresti
country: Romania
facility: Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu
city: Bratislava
country: Slovakia
facility: Metabolicke centrum MUDr. Katariny Raslovej, s.r.o.
city: Bratislava
country: Slovakia
facility: Medispektrum Plus, s.r.o.
city: Lucenec
country: Slovakia
facility: IN-DIA, s.r.o.
city: Nitra
country: Slovakia
facility: MUDr. Zuzana Ochodnicka, Interna diabetologicka ambulancia, s.r.o.
city: Nove Mesto nad Vahom
country: Slovakia
facility: NOEMIS, s.r.o.
city: Presov
country: Slovakia
facility: DIABETOL, s.r.o.
city: Trebisov
country: Slovakia
facility: Areteus, s.r.o.
city: Trencin
country: Slovakia
facility: Diabetes centrum, s.r.o.
city: Bloemfontein
country: South Africa
facility: Bloemfontein Medi-Clinic
state: Free State
city: Johannesburg
country: South Africa
facility: Dr DR Lakha's Practice
state: Gauteng
city: Midrand
country: South Africa
facility: Midrand Medical Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Medi-Clinic Heart Hospital
state: Gauteng
city: Waverley
country: South Africa
facility: Dr Bhana
state: Gauteng
city: Kimberley
country: South Africa
facility: Dr JH Mynhardt
state: Northern Cape
city: Durban
country: South Africa
facility: Randles Road Medical Centre
city: Moloto
country: South Africa
facility: AA Mahomed Medical Centre
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital, Division of Endocrinology and Metabolism
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital, Division of Metabolism and Endocrinology
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
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.