Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
834

Inclusion Criterias

Diagnosis of type 2 diabetes mellitus.
Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
Male and female patients on diet and exercise regimen who are:
Diagnosis of type 2 diabetes mellitus.
Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
Male and female patients on diet and exercise regimen who are:

Exclusion Criterias

Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
Bariatric surgery within the past two years.
...
Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
Bariatric surgery within the past two years.
Moderate to severe renal impairment.
Indication of liver disease.
Treatment with anti-obesity drugs 3 months prior to informed consent.
Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.
Current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.

Summary

Conditions
Diabetes Mellitus, Type 2
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Diagnosis of type 2 diabetes mellitus.
Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
Male and female patients on diet and exercise regimen who are:
Diagnosis of type 2 diabetes mellitus.
Treatment-naïve, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomisation.
Male and female patients on diet and exercise regimen who are:

Exclusion Criterias

Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
Bariatric surgery within the past two years.
...
Any other antidiabetic drug within 10 weeks prior to randomisation except metformin (applicable to patients on background treatment with metformin).
Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent.
Bariatric surgery within the past two years.
Moderate to severe renal impairment.
Indication of liver disease.
Treatment with anti-obesity drugs 3 months prior to informed consent.
Any other antidiabetic drug within 12 weeks prior to randomisation (applicable to treatment-naïve patients).
Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15 mmol/L) after an overnight fast during dose stabilisation (if applicable) and/or placebo run-in.
Current treatment with systemic steroids at time of informed consent or any other uncontrolled endocrine disorder except type 2 diabetes mellitus.

Tracking Information

NCT #
NCT01984606
Collaborators
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim