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Trial record 27 of 751 for:    Area Under Curve AND meal

Vildagliptin Versus Dapagliflozin on Glucagon

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ClinicalTrials.gov Identifier: NCT02475070
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bo Ahren, Lund University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Type 2 Diabetes
Interventions Drug: Vildagliptin
Drug: Dapagliflozin
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vildagliptin First Dapagliflozin First
Hide Arm/Group Description First intervention vildagliptin 50mg twice daily (2 weeks), Washout (4 weeks), Second intervention dapagliflozin 10mg once daily (2 weeks) First intervention dapagliflozin 10mg once Daily (2 weeks), washout (4 weeks), second intervention with vildaglipitn 50mg twice Daily (2 weeks)
Period Title: Overall Study
Started 17 11
Completed 17 11
Not Completed 0 0
Arm/Group Title Vildagliptin First Dapagliflozin First Total
Hide Arm/Group Description

Treatment with vildagliptin 50mg twice daily for two weeks followed by four weeks washout and then treatment with dapagliflozin 10mg once daily for two weeks

Vildagliptin: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks

Dapagliflozin: Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks

Treatment with dapagliflozin 10 mg once daily for two weeks followed by four weeks washout and then treatment with vildagliptin 50 mg twice daily for two weeks

Vildagliptin: Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks

Dapagliflozin: Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks

Total of all reporting groups
Overall Number of Baseline Participants 17 11 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 11 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
11
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 11 participants 28 participants
64  (7.3) 61  (6.7) 63  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 11 participants 28 participants
Female
13
  76.5%
7
  63.6%
20
  71.4%
Male
4
  23.5%
4
  36.4%
8
  28.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 11 participants 28 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
0
   0.0%
0
   0.0%
0
   0.0%
White
17
 100.0%
11
 100.0%
28
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 17 participants 11 participants 28 participants
17 11 28
1.Primary Outcome
Title Glucagon Response to Meal
Hide Description Area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150,180 and 240 minutes post-dose)
Time Frame 240 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vildagliptin Treatment Dapagliflozin Treatment
Hide Arm/Group Description:
Vildagliptin 50mg twice daily for 2 weeks
Dapagliflozin 10mg once Daily for 2 weeks
Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: nmol/l min
39.0  (2.6) 38.8  (2.7)
2.Secondary Outcome
Title Incretin Hormones
Hide Description Area under the curve (AUC) of the 180 min glucagon like peptide-1 levels after mixed meal (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 minutes post-dose)
Time Frame 240min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vildagliptin Treatment Dapagliflozin Treatment
Hide Arm/Group Description:
Vildagliptin 50mg twice daily for 2 weeks
Dapagliflozin 10mg once daily for 2 weeks
Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: nmol/l min
3.8  (0.5) 3.7  (0.5)
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vildagliptin Dapagliflozin
Hide Arm/Group Description Treatment with vildagliptin 50mg twice daily for two weeks Treatment with dapagliflozin 10 mg once daily for two weeks
All-Cause Mortality
Vildagliptin Dapagliflozin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vildagliptin Dapagliflozin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Vildagliptin Dapagliflozin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/28 (14.29%)      5/28 (17.86%)    
Infections and infestations     
common cold *  1/28 (3.57%)  1 1/28 (3.57%)  1
Metabolism and nutrition disorders     
Thirst *  1/28 (3.57%)  1 2/28 (7.14%)  2
Musculoskeletal and connective tissue disorders     
Myalgia *  2/28 (7.14%)  2 1/28 (3.57%)  1
Nervous system disorders     
Fatigue *  1/28 (3.57%)  1 1/28 (3.57%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Bo Ahrén
Organization: Lund University
Phone: +46462220758
EMail: Bo.Ahren@med.lu.se
Layout table for additonal information
Responsible Party: Bo Ahren, Lund University
ClinicalTrials.gov Identifier: NCT02475070     History of Changes
Other Study ID Numbers: 350A
First Submitted: June 15, 2015
First Posted: June 18, 2015
Results First Submitted: November 9, 2017
Results First Posted: May 2, 2019
Last Update Posted: May 2, 2019