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Completed

NCT Number: NCT01294436

Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

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Key information

Conditions

Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders High Blood Sugar Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures
  • Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)
  • diagnosed with type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

Exclusion criteria

  • Type 1 diabetes mellitus,
  • FPG >240 mg/dL before treatment started
  • Subjects who have history of unstable or rapidly progressing renal disease
  • Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
  • Significant cardiovascular history

Treatment and study plan

Dapagliflozin

Drug

Oral Dose 5 or 10 mg

Primary outcomes

  1. Proportion of Participants With Adverse Events

    Time frame: Long-term treatment up to 52 weeks

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events

  2. Proportion of Participants With Serious Adverse Events

    Time frame: Long-term treatment up to 52 weeks

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events

  3. Proportion of Participants With At Least One Episode of Hypoglycemia

    Time frame: Long-term treatment up to 52 weeks

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia

  4. Mean Change in Hematocrit

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit

  5. Mean Change in Alanine Aminotransferase (ALT)

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase

  6. Mean Change in Aspartate Aminotransferase (AST)

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase

  7. Mean Change in Blood Urea Nitrogen (BUN)

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen

  8. Mean Change in Magnesium

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)

  9. Mean Change in Serum Uric Acid

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid

  10. Mean Change in Seated Heart Rate

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse

  11. Mean Change in Seated Diastolic Blood Pressure

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure

  12. Mean Change in Seated Systolic Blood Pressure

    Time frame: Baseline to Week 52

    To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure

Other outcomes

  1. Mean Change in HbA1c Levels

    Time frame: Baseline to Week 52

    To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c

  2. Mean Change in Body Weight

    Time frame: Baseline to Week 52

    To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 11, 2011
Registry last updated
Dec 17, 2013

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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