Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ADA Linagliptin in Long Term Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02061969
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes
Interventions Drug: linagliptin
Drug: insulin glargine
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Period Title: Overall Study
Started 73 67
Completed 73 67
Not Completed 0 0
Arm/Group Title Insulin Glargine Linagliptin Total
Hide Arm/Group Description

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine.

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets.

Total of all reporting groups
Overall Number of Baseline Participants 73 67 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 67 participants 140 participants
71.5  (13) 68  (14) 69.8  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 67 participants 140 participants
Female
48
  65.8%
35
  52.2%
83
  59.3%
Male
25
  34.2%
32
  47.8%
57
  40.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 67 participants 140 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
42
  57.5%
42
  62.7%
84
  60.0%
White
30
  41.1%
22
  32.8%
52
  37.1%
More than one race
1
   1.4%
3
   4.5%
4
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 73 participants 67 participants 140 participants
73 67 140
1.Primary Outcome
Title Mean Fasting Blood Glucose Level
Hide Description The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: mg/dl
136.4  (35) 131.2  (27)
2.Secondary Outcome
Title HbA1c
Hide Description HbA1c at 6 month
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: percent of glycosylated hemoglobin
6.58  (0.7) 6.82  (0.6)
3.Secondary Outcome
Title Number of Hypoglycemic Events < 70mg/dl
Hide Description total number of hypoglycemic events (<70 mg/dl)
Time Frame over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Number
Unit of Measure: events
136 3
4.Secondary Outcome
Title Number of Hypoglycemic Events < 40mg/dl
Hide Description total number of severe hypoglycemia (< 40 mg/dl).
Time Frame over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Number
Unit of Measure: events
3 0
5.Secondary Outcome
Title Total Daily Dose of Insulin
Hide Description Total daily dose of insulin (units)
Time Frame over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: U/day
12.0  (9.9) 4.03  (1.7)
6.Secondary Outcome
Title Changes in Cognitive Function
Hide Description Data on changes in cognitive function were not collected
Time Frame over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Acute Complications
Hide Description Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).
Time Frame over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Count of Participants
Unit of Measure: Participants
8
  11.0%
5
   7.5%
8.Secondary Outcome
Title Total Number of Emergency Room Visits
Hide Description Total number of emergency room visits during the study period
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Number
Unit of Measure: visits
3 0
9.Secondary Outcome
Title Total Number of Hospital Visits
Hide Description Total number of hospital visits during the study period
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Number
Unit of Measure: visits
6 7
10.Secondary Outcome
Title Total Number of Complications
Hide Description Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Number
Unit of Measure: events
22 16
11.Secondary Outcome
Title Incidence of Acute Kidney Injury
Hide Description Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy
Time Frame over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Number
Unit of Measure: events
2 1
12.Secondary Outcome
Title Mortality
Hide Description Mortality is defined as death occurring during admission at the LTC facility
Time Frame over 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description:

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

Overall Number of Participants Analyzed 73 67
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   3.0%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Glargine Linagliptin
Hide Arm/Group Description

Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

Insulin glargine

Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.

linagliptin: 5mg linagliptin tablets

All-Cause Mortality
Insulin Glargine Linagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)      2/67 (2.99%)    
Hide Serious Adverse Events
Insulin Glargine Linagliptin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/73 (8.22%)      4/67 (5.97%)    
Cardiac disorders     
Hospitalization for congestive heart failure ( exacerbation *  1/73 (1.37%)  1 0/67 (0.00%)  0
Hospitalized for severe aortic stenosis *  0/73 (0.00%)  0 1/67 (1.49%)  1
Infections and infestations     
Right stump infection *  1/73 (1.37%)  1 0/67 (0.00%)  0
Wound infection *  0/73 (0.00%)  0 1/67 (1.49%)  1
Nervous system disorders     
Hospitalized for brain edema *  1/73 (1.37%)  1 0/67 (0.00%)  0
Psychiatric disorders     
Hospitalized for Altered Mental Status *  0/73 (0.00%)  0 1/67 (1.49%)  1
Respiratory, thoracic and mediastinal disorders     
Hospitalized for aspiration pneumonia *  1/73 (1.37%)  1 0/67 (0.00%)  0
Hospitalization for pleural effusion *  1/73 (1.37%)  1 0/67 (0.00%)  0
Surgical and medical procedures     
Hospitalized for repair craninectomy *  1/73 (1.37%)  1 0/67 (0.00%)  0
Amputation of the left 2nd toe *  0/73 (0.00%)  0 1/67 (1.49%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin Glargine Linagliptin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/73 (21.92%)      12/67 (17.91%)    
Blood and lymphatic system disorders     
Anemia *  1/73 (1.37%)  1 0/67 (0.00%)  0
Cardiac disorders     
Chest pain *  0/73 (0.00%)  0 1/67 (1.49%)  1
Bradicardia *  1/73 (1.37%)  1 0/67 (0.00%)  0
Hypotension *  1/73 (1.37%)  1 0/67 (0.00%)  0
Gastrointestinal disorders     
Nausea *  0/73 (0.00%)  0 1/67 (1.49%)  1
Diarrhea *  0/73 (0.00%)  0 1/67 (1.49%)  1
Musculoskeletal and connective tissue disorders     
Fall *  1/73 (1.37%)  1 1/67 (1.49%)  1
Renal and urinary disorders     
Hematuria *  0/73 (0.00%)  0 1/67 (1.49%)  1
Urinary Tract Infection *  6/73 (8.22%)  6 3/67 (4.48%)  3
Acute Kidney Injury *  0/73 (0.00%)  0 1/67 (1.49%)  1
Acute renal failure *  3/73 (4.11%)  3 0/67 (0.00%)  0
Reproductive system and breast disorders     
Penile infection *  1/73 (1.37%)  1 0/67 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  2/73 (2.74%)  2 1/67 (1.49%)  1
Skin and subcutaneous tissue disorders     
Shingels *  0/73 (0.00%)  0 2/67 (2.99%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Saumeth Cardona MD
Organization: Emory University
Phone: 404-616-4827
EMail: scardon@emory.edu
Layout table for additonal information
Responsible Party: Guillermo Umpierrez, MD, Emory University
ClinicalTrials.gov Identifier: NCT02061969    
Other Study ID Numbers: IRB00071545
IRB00071946 ( Other Identifier: VA site IRB number )
First Submitted: February 11, 2014
First Posted: February 13, 2014
Results First Submitted: May 8, 2018
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018