A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01469065
• Date of registration: 25/10/2011
• Primary sponsor: Pfizer
• Public title: A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes
• Scientific title: A 2-week, Phase 1, Placebo-Controlled, Parallel Group Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Oral Doses Of PF-04991532 Given As Monotherapy To Adult Patients With Type 2 Diabetes Mellitus
• Date of first enrolment: December 2011
• Target sample size: 82
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01469065
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Countries of recruitment

Japan, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with type 2 diabetes mellitus who are taking either no medication for the
treatment of diabetes (diet/exercise therapy only), or who are taking only a single
oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately
8-10 weeks. For those taking a single OAD, treatment should be stable, where this is
defined as no change in the treatment, including dose, over the past 3 months prior
to Screening. OAD medications that are acceptable to be discontinued include: a
sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase
4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.

- Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110
lbs).

- HbA1c >/=7% and require any OAD discontinuation. HbA1c >/=6.5% and be washed off an OAD.

Exclusion Criteria:

- Evidence or history of diabetic complications with significant end organ damage.

- History of stroke or transient ischemic attack.

- History of myocardial infarction.

- History of coronary artery bypass graft or stent implantation.

- Clinically significant peripheral vascular disease.

- Any history or clinical evidence of congestive heart failure, NYHA Classes II IV.

- Current history of angina/unstable angina.

- One or more episodes of hypoglycemia within the last 3 months, or two or more
episodes of hypoglycemia within the last 6 months.

- A positive urine drug screen.

- Use of tobacco or nicotine-containing products in excess of the equivalent of 10
cigarettes per day.

- Blood pressure >/=160 mm Hg (systolic) or >/=100 mm Hg (diastolic), following at
least 5 minutes of rest.

- Pregnant or nursing females; females of childbearing potential.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: PF-0499132

Drug: PF-04991532

Drug: Placebo

Primary Outcome(s)

Glucose response (Day 14 versus Day -1 baseline) for mean daily glucose (MDG; average of 8 timepoints throughout the day) [Time Frame: 2 weeks]

Safety and tolerability data (number of subjects wtih adverse events, and changes from baseline in standard safety laboratory tests, pulse rate, blood pressure, and ECG measurements over 14 days) [Time Frame: 2 weeks]

Secondary Outcome(s)

Glucose response (Day 13 versus Day -2 baseline) for mean daily glucose (MDG; average of 8 timepoints throughout the day) [Time Frame: 2 weeks]

Glucose response (Day 14 versus Day -1 baseline) for a mixed meal tolerance test (MMTT) glucose area under the curve (AUC) [Time Frame: 2 weeks]

Glucose response (Days 1, 3, 6, 10, and 14 versus baseline) for fasting plasma glucose (FPG) [Time Frame: 2 weeks]

Insulin and C-peptide responses (Day 14 versus baseline) during a mixed meal tolerance test (MMTT) [Time Frame: 2 weeks]

Profile of pharmacokinetics; timeframe: 0, 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, and 18 hours (post dosing Days 1 and 14), and 24, 36, and 48 hours (post dosing Day 14). Parameters: Cmax, area under the curve over 24 hours (AUC24), Tmax [Time Frame: 2 weeks]

Standard lipid panel characterization (post-treatment Days vs. baseline) [Time Frame: 2 weeks]

Secondary ID(s)

B2611005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors