Trial Outcomes & Findings for Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus (NCT NCT02426541)
NCT ID: NCT02426541
Last Updated: 2018-02-05
Results Overview
Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
55 participants
Primary outcome timeframe
From baseline to Week 8
Results posted on
2018-02-05
Participant Flow
A total of 55 subjects were enrolled and 32 subjects were randomised and treated. One participant was withdrawn prior to study completion. Thirty-one participants completed the study and attended all visits.
Participant milestones
| Measure |
Dapagliflozin 10 MG
Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Placebo
Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dapagliflozin 10 MG
Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Placebo
Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Dapagliflozin 10 MG
n=15 Participants
Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Placebo
n=16 Participants
Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 8Population: Full analysis set
Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)
Outcome measures
| Measure |
Dapagliflozin 10 MG
n=15 Participants
Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Placebo
n=16 Participants
Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
|---|---|---|
|
Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake
|
0.28 umol/min/kg
Standard Error 1.23
|
0.28 umol/min/kg
Standard Error 1.13
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set
Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET
Outcome measures
| Measure |
Dapagliflozin 10 MG
n=15 Participants
Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Placebo
n=16 Participants
Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
|---|---|---|
|
Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake
|
1.04 umol/min/kg
Standard Error 1.50
|
-0.64 umol/min/kg
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Full analysis set
Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET
Outcome measures
| Measure |
Dapagliflozin 10 MG
n=15 Participants
Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Placebo
n=16 Participants
Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
|---|---|---|
|
Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8
|
0.27 umol/min/kg
Standard Error 1.74
|
1.59 umol/min/kg
Standard Error 1.52
|
Adverse Events
Dapagliflozin 10 MG
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapagliflozin 10 MG
n=16 participants at risk
Dapagliflozin 10 MG added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
Placebo
n=16 participants at risk
Placebo added to stable metformin, dipeptidyl pepdidase-4 (DPP-IV) inhibitor, or sulphonylurea alone or in combination with either metformin or DPP-IV inhibitor antidiabetic medication.
|
|---|---|---|
|
Infections and infestations
Balanitis candida
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/16 • 8 weeks
|
|
Infections and infestations
Respiratory tract infection
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
12.5%
2/16 • Number of events 2 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/16 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
|
General disorders
Astenia
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
|
General disorders
Thirst
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/16 • 8 weeks
|
|
Investigations
Blood glucose decreased
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/16 • 8 weeks
|
|
Renal and urinary disorders
Polyuria
|
25.0%
4/16 • Number of events 4 • 8 weeks
|
0.00%
0/16 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
0.00%
0/16 • 8 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • 8 weeks
|
6.2%
1/16 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All drafts of proposed publications, written reports, training materials, advertisements and similar documents related to the Services and intended to be communicated or published to any third party ("Communications") must be submitted to Antaros for AstraZeneca's review and approval prior to dissemination.
- Publication restrictions are in place
Restriction type: OTHER