Trial Outcomes & Findings for Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes (NCT NCT02700334)
NCT ID: NCT02700334
Last Updated: 2020-10-28
Results Overview
The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
Fasting Glucose levels at week 12
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 8.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Fasting Glucose
|
5.9 mmol/L
STANDARD_DEVIATION 0.4 • n=5 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 0.4 • n=7 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Postprandial Glucose
|
9.2 mmol/L
STANDARD_DEVIATION 1.4 • n=5 Participants
|
9.5 mmol/L
STANDARD_DEVIATION 1.4 • n=7 Participants
|
9.4 mmol/L
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
First Phase of Insulin Secretion
|
1126 index
STANDARD_DEVIATION 604 • n=5 Participants
|
1708 index
STANDARD_DEVIATION 709 • n=7 Participants
|
1417 index
STANDARD_DEVIATION 656.5 • n=5 Participants
|
|
Total Insulin Secretion
|
0.69 index
STANDARD_DEVIATION 0.31 • n=5 Participants
|
0.49 index
STANDARD_DEVIATION 0.17 • n=7 Participants
|
0.6 index
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Insulin Sensitivity
|
1.78 index
STANDARD_DEVIATION 1.09 • n=5 Participants
|
1.94 index
STANDARD_DEVIATION 0.72 • n=7 Participants
|
1.9 index
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Glycosylated Hemoglobin
|
5.8 percentage
STANDARD_DEVIATION 0.3 • n=5 Participants
|
5.8 percentage
STANDARD_DEVIATION 0.5 • n=7 Participants
|
5.8 percentage
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Body Weight
|
80.8 kg
STANDARD_DEVIATION 16.3 • n=5 Participants
|
83.5 kg
STANDARD_DEVIATION 8.2 • n=7 Participants
|
82.2 kg
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Body Mass Index
|
30.3 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
33.0 kg/m^2
STANDARD_DEVIATION 2.2 • n=7 Participants
|
31.7 kg/m^2
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Total Cholesterol
|
5.0 mmol/L
STANDARD_DEVIATION 0.9 • n=5 Participants
|
4.7 mmol/L
STANDARD_DEVIATION 0.6 • n=7 Participants
|
4.9 mmol/L
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Triglycerides
|
1.5 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
1.4 mmol/L
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.5 mmol/L
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
High Density Lipoprotein cholesterol (HDL-c)
|
1.6 mmol/L
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.5 mmol/L
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.6 mmol/L
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Alanine Aminotransferase (ALT)
|
33.3 IU/L
STANDARD_DEVIATION 16.0 • n=5 Participants
|
37.1 IU/L
STANDARD_DEVIATION 26.8 • n=7 Participants
|
35.2 IU/L
STANDARD_DEVIATION 21.4 • n=5 Participants
|
|
Aspartate Aminotransferase (AST)
|
36.0 IU/L
STANDARD_DEVIATION 8.0 • n=5 Participants
|
32.7 IU/L
STANDARD_DEVIATION 19.6 • n=7 Participants
|
34.4 IU/L
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Creatinine
|
0.06 mmol/L
STANDARD_DEVIATION 0.01 • n=5 Participants
|
0.07 mmol/L
STANDARD_DEVIATION 0.02 • n=7 Participants
|
0.07 mmol/L
STANDARD_DEVIATION 0.02 • n=5 Participants
|
|
Uric Acid
|
334 μmol/L
STANDARD_DEVIATION 70 • n=5 Participants
|
312 μmol/L
STANDARD_DEVIATION 101 • n=7 Participants
|
323 μmol/L
STANDARD_DEVIATION 85.5 • n=5 Participants
|
|
Systolic Blood Pressure
|
124 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
126 mmHg
STANDARD_DEVIATION 11 • n=7 Participants
|
125 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Diastolic Blood Pressure
|
78 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
77 mmHg
STANDARD_DEVIATION 11 • n=7 Participants
|
78 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
PRIMARY outcome
Timeframe: Fasting Glucose levels at week 12The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Fasting Glucose
|
5.1 mmol/L
Standard Deviation 0.3
|
5.9 mmol/L
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Postprandial Glucose levels at Week 12Postprandial glucose will be evaluated after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Postprandial Glucose
|
8.4 mmol/L
Standard Deviation 1.5
|
8.7 mmol/L
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: First Phase of Insulin Secretion at Week 12The first phase of insulin secretion will be calculated with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
First Phase of Insulin Secretion
|
1096 index
Standard Deviation 388
|
1379 index
Standard Deviation 566
|
PRIMARY outcome
Timeframe: Total Insulin Secretion at Week 12Total insulin secretion will be calculated with insulinogenic index and the entered values reflect the total insulin secretion at week 12. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Total Insulin Secretion
|
0.50 index
Standard Deviation 0.18
|
0.67 index
Standard Deviation 0.33
|
PRIMARY outcome
Timeframe: Insulin Sensitivity at Week 12Insulin sensitivity will be calculated with Matsuda index and the entered values reflect the insulin sensitivity at week 12. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Insulin Sensitivity
|
2.63 index
Standard Deviation 1.04
|
1.94 index
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: Glycosylated Hemoglobin at Week 12Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Glycosylated Hemoglobin
|
5.7 percentage
Standard Deviation 0.3
|
5.9 percentage
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Body Weight at Week 12The body weight will be measured with a bioimpedance balance and the entered values reflect the body weight at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Body Weight
|
77.8 kg
Standard Deviation 14.9
|
82.5 kg
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Body Mass Index at Week 12Body Mas Index will be calculated with the Quetelet index formula and the entered values reflect the body mass index at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Body Mass Index
|
29.2 kg/m^2
Standard Deviation 3.1
|
32.6 kg/m^2
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Total Cholesterol levels at Week 12Total cholesterol levels will be evaluated by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Total Cholesterol
|
4.8 mmol/L
Standard Deviation 0.9
|
4.7 mmol/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Triglycerides levels at Week 12Triglycerides levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Triglycerides
|
1.5 mmol/L
Standard Deviation 0.7
|
1.6 mmol/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: HDL-c levels at Week 12HDL-c levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
High Density Lipoprotein Cholesterol (HDL-c)
|
1.5 mmol/L
Standard Deviation 0.7
|
1.6 mmol/L
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: ALT levels at Week 12ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Alanine Aminotransferase (ALT)
|
29.3 IU/L
Standard Deviation 13.6
|
27.7 IU/L
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: AST levels at Week 12AST levels will be evaluated with enzymatic/colorimetric techniques at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Aspartate Aminotransferase (AST)
|
29.3 IU/L
Standard Deviation 13.6
|
27.7 IU/L
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Creatinine levels at Week 12Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Creatinine
|
79.6 µmol/L
Standard Deviation 35.4
|
61.9 µmol/L
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Uric Acid levels at Week 12Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Uric Acid
|
261.7 µmol/L
Standard Deviation 59.5
|
303.4 µmol/L
Standard Deviation 83.3
|
SECONDARY outcome
Timeframe: Systolic Blood Pressure at Week 12Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Systolic Blood Pressure
|
124 mmHg
Standard Deviation 12
|
123 mmHg
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Diastolic Blood Pressure at Week 12Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 Participants
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Diastolic Blood Pressure
|
77 mmHg
Standard Deviation 10
|
74 mmHg
Standard Deviation 10
|
Adverse Events
Dapagliflozin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapagliflozin
n=12 participants at risk
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin: 10 mg, one per day before breakfast during 12 weeks.
|
Placebo
n=12 participants at risk
Placebo capsules, one per day before breakfast during 12 weeks.
Placebo: one per day before breakfast during 12 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Adverse events were collected throughout the study (12 weeks)
|
25.0%
3/12 • Number of events 3 • Adverse events were collected throughout the study (12 weeks)
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Number of events 2 • Adverse events were collected throughout the study (12 weeks)
|
16.7%
2/12 • Number of events 2 • Adverse events were collected throughout the study (12 weeks)
|
|
Skin and subcutaneous tissue disorders
Edema in upper extremities
|
8.3%
1/12 • Number of events 1 • Adverse events were collected throughout the study (12 weeks)
|
8.3%
1/12 • Number of events 1 • Adverse events were collected throughout the study (12 weeks)
|
|
Renal and urinary disorders
Urinary tract infection
|
16.7%
2/12 • Number of events 2 • Adverse events were collected throughout the study (12 weeks)
|
0.00%
0/12 • Adverse events were collected throughout the study (12 weeks)
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected throughout the study (12 weeks)
|
0.00%
0/12 • Adverse events were collected throughout the study (12 weeks)
|
Additional Information
DR. MANUEL GONZALEZ ORTIZ
INSTITUTO DE TERAPUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA
Phone: +52 3310585200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place