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NCT Number: NCT00554450

Renal Impairment in Type 2 Diabetic Subjects

The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Clinical Research Institute, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Subjects in the following groups:

Group A: Healthy Subjects with Normal Renal Function (CLcr > 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr > 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr > 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr < 30 mL/min) (and not receiving dialysis)

  • Men and WOCBP, ages 18 to 79 years old

Standard Exclusion Criteria, plus:

  • History of diabetic ketoacidosis
  • HbA*1c > 10%
  • Serum albumin < 2.0 gm/dL
  • Potassium < 3.0 or > 6.0 mEq/L

Treatment and study plan

Dapagliflozin

Drug

Tablets, Oral, once daily

Primary outcomes

  1. Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine

    Time frame: on Days -1, 1, 4 and 10

  2. Blood samples for serum glucose and creatinine will be collected

    Time frame: on Days -1, 1, 4 and 10 at selected timepoints

  3. Blood and urine PK samples

    Time frame: on Days 1, 4, 10

  4. Iohexol PK blood & urine samples for GFR assessment

    Time frame: on Day -12 to -5

Secondary outcomes

  1. AEs, vital signs

    Time frame: scr, Days -1, 1, 4-11, discharge

  2. physical exams

    Time frame: scr, Days -12 to -5, -1, discharge

  3. ECGs

    Time frame: scr, Days,-1, 4, 7, discharge

  4. clinical labs

    Time frame: scr, Day -1, 1, 4, 6, 8, 10, discharge

  5. The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only)

    Time frame: on Days -1, 1, 4 and 10

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 7, 2007
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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