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Completed

NCT Number: NCT00881530

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1245.24.431002 Boehringer Ingelheim Investigational Site, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients completing one of double blind phase II trials 1245.9 or 1245.10
  • informed consent

Exclusion criteria

  • patients meeting withdrawal criteria of preceding trial
  • significant hepatic impairment
  • significant renal impairment with creatinine clearance < 50 ml/min
  • contraindication to Metformin for all patients treated with Metformin
  • premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control
  • drug or alcohol abuse

Treatment and study plan

BI 10773

Drug

BI 10773 high dose once daily

metformin

Drug

open label comparator

Sitagliptin

Drug

open label comparator

Primary outcomes

  1. Hypoglycaemic Events

    Time frame: 78 weeks plus 1 week of follow-up

    Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration:

    • Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L)
    • Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L)
    • Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance
    • Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions

  2. Change From Baseline to Week 78 in Lipid Parameters

    Time frame: Weeks 1 and 78

    Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)

  3. Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements

    Time frame: 78 weeks plus 1 week of follow-up

    Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.

Secondary outcomes

  1. Change From Baseline in HbA1c Over Time

    Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78

    Baseline source: before first intake of active treatment (preceding trial or Open label extension)

  2. Occurence of a Treat-to-target Response (HbA1c < 7.0%)

    Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78

    Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time

  3. Occurrence of a Treat-to-target Response (HbA1c < 6.5%)

    Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78

    Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time

  4. Occurrence of a Relative Efficacy Response

    Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78

    Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time)

  5. Change From Baseline in Fasting Plasma Glucose (FPG) Over Time

    Time frame: Weeks 1, 6, 18, 30, 42, 54, 66 and 78

    Baseline source: before first intake of active treatment (preceding trial or Open label extension)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

Important dates

Study start
2009
Primary completion
2011
First posted
Apr 15, 2009
Registry last updated
Jun 16, 2014

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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