Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)

NCT01165268 | Completed Phase 1

• 1 other identifier: MB102-066
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin

  Before 7 days of oral administration of 10 mg of dapagliflozin

• The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin

  After 7 days of oral administration of 10 mg of dapagliflozin

Secondary Outcomes (4)

• Splay of the glucose titration curve

  Before 7 days of oral administration of 10 mg of dapagliflozin

• Splay of the glucose titration curve

  After 7 days of oral administration of 10 mg of dapagliflozin

• Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin

  Study Day 7

• Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin

  Study Day 8

Study Arms (2)

Dapagliflozin (T2DM)

ACTIVE COMPARATOR

Drug: Dapagliflozin

Dapagliflozin (Healthy Subjects)

ACTIVE COMPARATOR

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

Tablets, Oral, 10 mg, Once daily, 7 days

Dapagliflozin (Healthy Subjects); Dapagliflozin (T2DM)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of T2DM
• Must be on one of the following therapies: diet therapy alone, diet plus a sulfonylurea, diet plus metformin, or diet plus sulfonylurea plus metformin
• Subjects taking metformin, and/or sulfonylurea must be on a stable dose for at least 2 months prior to study drug administration
• Must have a fasting plasma glucose concentration ≤ 200 mg/dl, and HbA1C ≤ 10%
• Healthy subjects (as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations)
• Subjects with (eGFR ≥ 60 and ≤ 160 mL/min/1.73m² and urinary albumin excretion \< 300 mg/g creatinine)
• Body Mass Index (BMI) of 18 to 38 kg/m²
• Men and women, ages 18 to 65 years, inclusive

You may not qualify if:

• Subjects with Type 1 Diabetes or uncontrolled Type 2 Diabetes Mellitus
• Subjects with T2DM with fasting plasma glucose \> 200 mg/dL, healthy subjects with fasting plasma glucose \> 105 mg/dL
• Subjects with T2DM with HbA1C \> 10.0%, healthy subjects with HbA1C \> 6.8%

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Profil Institute For Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

Related Links

• MB102-066\_CSR\_synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 19, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

US (1)