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Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01438814
First received: September 21, 2011
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: February 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: metformin placebo
Drug: linagliptin placebo
Drug: metformin
Drug: linagliptin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lina 5mg + Met qd Patients treated with Linagliptin 5mg in combination with metformin once daily.
Met Bid Patients treated with metformin alone twice daily.

Participant Flow:   Overall Study
    Lina 5mg + Met qd     Met Bid  
STARTED     344     345  
COMPLETED     330     331  
NOT COMPLETED     14     14  
Adverse Event                 3                 3  
Protocol Violation                 1                 2  
Lost to Follow-up                 4                 3  
Withdrawal by Subject                 4                 2  
Not specified                 2                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS): all patients treated with at least 1 dose of randomised study medication

Reporting Groups
  Description
Lina 5mg + Met qd Patients treated with Linagliptin 5mg in combination with metformin once daily.
Met Bid Patients treated with metformin alone twice daily.
Total Total of all reporting groups

Baseline Measures
    Lina 5mg + Met qd     Met Bid     Total  
Number of Participants  
[units: participants]
  344     345     689  
Age  
[units: years]
Mean ± Standard Deviation
  53.1  ± 10.7     52.9  ± 10.7     53.0  ± 10.7  
Gender  
[units: participants]
     
Female     175     187     362  
Male     169     158     327  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment   [ Time Frame: Baseline and 14 weeks ]

2.  Secondary:   Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment   [ Time Frame: 14 weeks ]

3.  Secondary:   Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment   [ Time Frame: 14 weeks ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment   [ Time Frame: Baseline and 14 weeks ]

5.  Secondary:   Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment   [ Time Frame: 14 weeks ]

6.  Secondary:   Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment   [ Time Frame: 14 weeks ]

7.  Secondary:   Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators   [ Time Frame: 14 weeks ]

8.  Secondary:   Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)   [ Time Frame: 14 weeks ]

9.  Secondary:   Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)   [ Time Frame: 14 weeks ]

10.  Secondary:   Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks   [ Time Frame: 14 weeks ]

11.  Secondary:   Change From Baseline in Body Weight by Visit at Week 14   [ Time Frame: Baseline and 14 weeks ]

12.  Secondary:   Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks   [ Time Frame: 14 weeks ]

13.  Secondary:   Change From Baseline in HbA1c Over Time   [ Time Frame: Baseline, 2 weeks and 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01438814     History of Changes
Other Study ID Numbers: 1218.60, 2011-002276-16
Study First Received: September 21, 2011
Results First Received: February 28, 2014
Last Updated: November 13, 2014
Health Authority: Bangladesh: Directorate of Drug Administration
Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
China: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Guatemala: Ministry of Public Health and Social Assistance
Hong Kong: Department of Health
India: Drugs Controller General of India
Lebanon: Ministry of Public Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Spain: Spanish Agency of Medicines
Taiwan : Food and Drug Administration