Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01734785
First received: November 16, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
This trial will compare the use of the FDC of empagliflozin and linagliptin to linagliptin alone as add-on to metformin in patients with T2DM.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Linagliptin Drug: Empagliflozin + Linagliptin Drug: Empaglifozin placebo + Linagliptin placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- HbA1c change from baseline after 24 weeks double-blind randomized treatment [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Fasting plasma glucose (FPG) change from baseline after 24 weeks of double-blind treatment. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
- Body weight change from baseline after 24 weeks of double-blind treatment [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 444 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Linagliptin
5 mg once daily
|
Drug: Linagliptin
tablet
Drug: Empaglifozin placebo + Linagliptin placebo
Matching Empaglifozin + Linagliptin low dose
|
|
Experimental: Empaglifozin + Linagliptin low dose
1 tablet once daily
|
Drug: Empagliflozin + Linagliptin
Fixed dose combination.
Drug: Empagliflozin + Linagliptin
Fixed dose combination
|
|
Experimental: Empagliflozin + Linagliptin high dose
1 tablet once daily
|
Drug: Empagliflozin + Linagliptin
Fixed dose combination
Drug: Empagliflozin + Linagliptin
Fixed dose combination.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus.
- Male and female patients on diet and exercise regimen, pre-treated with immediate release metformin for at least 12 weeks, and patients should be on a dose higher or equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per local label.
- HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.
- Age 18 years or more at screening.
- Body Mass Index lower or equal to 45 kg/m2 at screening visit.
- Signed and dated written informed consent.
Exclusion criteria:
- Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after an overnight fast.
- Use of any other antidiabetic drug (except metformin background therapy).
- Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.
- Indication of liver disease.
- Impaired renal function.
- Gastrointestinal surgery.
- Treatment with anti-obesity drugs within 3 months prior to screening, or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
- Current treatment with systemic steroids at time of informed consent or uncontrolled endocrine disorder except type 2 diabetes mellitus.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734785
Show 78 Study Locations
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Show 78 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01734785 History of Changes |
| Other Study ID Numbers: | 1275.9, 2012-002270-31 |
| Study First Received: | November 16, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Australia: Dept of Health and Ageing Therapeutic Goods Administration Brazil: Ministry of Health France: Agence Nationale sécurité médicament et des produits santé India: Drugs Controller General of India New Zealand: Medsafe Norway: Norwegian Medicines Agency South Korea: Ministry of Food and Drug Safety (MFDS) Spain: Spanish Agency of Medicines Taiwan : Food and Drug Administration United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases BI 1356 Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013