A 6-Week Study To Determine The Safety And Effect Of An Investigational Drug Given With Canagliflozin In Adults With Type 2 Diabetes Mellitus Taking Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A 6-week Phase 2a Randomized, Double-Blind, Placebo-Controlled Study To Assess Safety, Tolerability And Pharmacodynamics Of Oral PF-05175157 Administered With Canagliflozin In Adult Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02053116
• Other study ID #: B1731006
• Status: Terminated
• Phase: Phase 2
• First received: January 30, 2014
• Last updated: May 16, 2014
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A Phase 2a study to evaluate the effects of an investigational compound administered at 200 mg, twice daily (BID), for 6 weeks, with canagliflozin, in adult subjects with Type 2 Diabetes Mellitus (T2DM).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with Type 2 Diabetes Mellitus and treated with metformin at a dose greater than or equal to 1000 mg for at least 3 months and are willing to switch to canagliflozin from metformin for the duration of the study

• Hemoglobin A1c of 7-10% at screening.

• Body Mass Index of at least 25 kg/m2.

Exclusion Criteria:

• Compliant with study drug administration during the run-in period and throughout the trial.

• Patients with fasting triglycerides greater than 500 mg/dL at screening.

• History of certain diabetic complications or cardiac problems.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• PF-05175157
Tablet, 200 mg, twice daily, 6 weeks
• Placebo
Tablet, 0 mg, twice daily, 2 weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	DeLand	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo		Week 0, 4	No
Secondary	Change from baseline in Weighted Mean Daily Glucose (WMDG) when compared to placebo		Weeks 0 and 4	No
Secondary	Change from baseline in fasting plasma glucose		Weeks 0, 2, 4 and 6	No
Secondary	Change from baseline in Glycosylated Hemoglobin (HbA1c)		Weeks 0, 4 and 6	No
Secondary	Change from baseline in fasting total cholesterol		Weeks 0, 4 and 6	No
Secondary	Change from baseline in glucose AUC(0-5) during mixed meal tolerance test (MMTT)		Weeks 0, 4 and 6	No
Secondary	Change from baseline in insulin AUC(0-5) during mixed meal tolerance test (MMTT)		Weeks 0, 4 and 6	No
Secondary	Change from baseline in C-peptide AUC(0-5) during mixed meal tolerance test (MMTT)		Weeks 0, 4 and 6	No
Secondary	Change from baseline in ratio of AUC(0-5) insulin to AUC(0-5) glucose during the MMTT		Weeks 0, 4 and 6	No
Secondary	Change from baseline in ratio of AUC (0-5) C-peptide to AUC(0-5) glucose during the MMTT		Weeks 0, 4 and 6	No
Secondary	Change from baseline in homeostatic model assessment for insulin resistance (HOMA IR)		Weeks 0, 4 and 6	No
Secondary	Change from baseline in homeostatic model assessment for ß-cell function (HOMA B)		Weeks 0, 4 and 6	No
Secondary	Change from baseline in low density lipoprotein cholesterol (LDL-C)		Weeks 0, 4 and 6	No
Secondary	Plasma concentrations for PF-05175157		Weeks 2, 4 and 6	No
Secondary	Percent change from baseline in body weight		Weeks 0, 4 and 6	No
Secondary	Change from baseline in high density lipoprotein cholesterol (HDL-C)		Weeks 0, 4 and 6	No
Secondary	Change from baseline in triglycerides		Weeks 0, 4 and 6	No
Secondary	Change from baseline in non-HDL cholesterol		Weeks 0, 4 and 6	No
Secondary	Change from baseline in very low density lipoprotein (VLDL)		Weeks 0, 4 and 6	No

External Links

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