Clinical trial NCT03538743: 4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE ESCALATING ORAL DOSES OF PF-06882961 IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes treated with a stable dose of metformin at least 500 mg
* HbA1c value between 7.0 and 10.5%

Exclusion Criteria:

- Type 1 diabetes or secondary forms of diabetes

Primary outcomes:
measure: Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline to up to 35 days after last dose for a total of approximately 63 days
measure: Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
timeFrame: From baseline to up to 14 days after last dose for a total of approximately 42 days
measure: Number of Participants With Abnormal Vital Signs
timeFrame: From baseline to up to 14 days after last dose for a total of approximately 42 days
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Interval
timeFrame: From baseline to up to 14 days after last dose for a total of approximately 42 days
Secondary outcomes:
measure: AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28
timeFrame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
measure: Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
timeFrame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours post dose on Day 1, 14 or 21, and 28
measure: Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28
timeFrame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 1, 14 or 21, and 28
measure: Terminal Half-life (t½) of PF-06882961 on Day 28
timeFrame: 0, 1, 2, 4, 6, 8, 10, 12, 14 and 24 hrs post dose on Day 28
measure: Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28
timeFrame: 0 to 24 hours post-dose on Day 28
measure: Ae24 (%) of PF-06882961 on Day 28
timeFrame: 0 to 24 hours post-dose on Day 28
measure: Renal Clearance (CLr) of PF-06882961 on Day 28
timeFrame: 0 to 24 hours post-dose on Day 28
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: South Miami
country: United States
facility: Qps-Mra,Llc
state: Florida
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas, Inc.
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Saxena AR, Gorman DN, Esquejo RM, Bergman A, Chidsey K, Buckeridge C, Griffith DA, Kim AM. Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial. Nat Med. 2021 Jun;27(6):1079-1087. doi: 10.1038/s41591-021-01391-w. Epub 2021 Jun 14.