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Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01512979
First received: January 16, 2012
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: April 8, 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
Drug: linagliptin
Drug: metformin placebo

  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
Linagliptin 5mg + Metformin Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
Linagliptin 5mg Patients treated with linagliptin 5mg

Participant Flow:   Overall Study
    Linagliptin 5mg + Metformin     Linagliptin 5mg  
STARTED     159 [1]   157 [1]
COMPLETED     140     135  
NOT COMPLETED     19     22  
Adverse Event                 2                 2  
Protocol Violation                 1                 4  
Lost to Follow-up                 2                 5  
Withdrawal by Subject                 1                 2  
Reason other than stated above                 13                 9  
[1] Randomised and treated



  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.
Patients from Treated Set (TS): All patients treated with at least 1 dose of study drug.

Reporting Groups
  Description
Linagliptin 5mg + Metformin Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
Linagliptin 5mg Patients treated with linagliptin 5mg
Total Total of all reporting groups

Baseline Measures
    Linagliptin 5mg + Metformin     Linagliptin 5mg     Total  
Number of Participants  
[units: participants]
  159     157     316  
Age  
[units: years]
Mean ± Standard Deviation
  49.0  ± 10.9     48.6  ± 11.2     48.8  ± 11.0  
Gender  
[units: participants]
     
Female     90     80     170  
Male     69     77     146  
Baseline HbA1c [1]
[units: percentage]
Mean ± Standard Deviation
  9.79  ± 1.19     9.88  ± 1.10     9.83  ± 1.14  
[1] Baseline HbA1c was analyzed for the Full Analysis Set which includes all patients randomised, treated with at least 1 dose of study drug, with a baseline HbA1c value and at least 1 on-treatment HbA1c value. The Linagliptin 5mg + Metformin group includes 153 participants, the Linagliptin 5mg group includes 150 participants (303 participants in total).



  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c After 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment   [ Time Frame: Baseline and 24 weeks ]

3.  Secondary:   Change From Baseline in HbA1c by Visit Over Time   [ Time Frame: Baseline, 6, 12, 18 and 24 weeks ]

4.  Secondary:   Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)   [ Time Frame: Baseline and 24 weeks ]

5.  Secondary:   Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)   [ Time Frame: Baseline and 24 weeks ]

6.  Secondary:   Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment   [ Time Frame: Baseline and 24 weeks ]

7.  Secondary:   Change From Baseline in FPG by Visit Over Time   [ Time Frame: Baseline, 6, 12, 18 and 24 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: NCT01512979     History of Changes
Other Study ID Numbers: 1218.83, 2011-004158-24
Study First Received: January 16, 2012
Results First Received: April 8, 2014
Last Updated: May 12, 2014
Health Authority: Canada: Health Canada
India: Drugs Controller General of India
Israel: Israeli Health Ministry Pharmaceutical Administration
Malaysia: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Philippines: Bureau of Food and Drugs
Russia: Pharmacological Committee, Ministry of Health
Sri Lanka: Ministry of Healthcare and Nutrition
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration