Trial Outcomes & Findings for Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes (NCT NCT00831779)

Last Updated: 2017-04-24

Results Overview

Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

From Baseline to Week 12

Results posted on

2017-04-24

Participant Flow

Of 116 participants enrolled, 50 completed a qualification period. Of these 50 participants, 44 were randomized and received treatment. Of these 44 participants, 42 completed double-blind treatment period.

Participant milestones

Participant milestones
Measure	Placebo + Background Anti-Diabetes Medication Placebo tablets, oral, once daily, 12 weeks	Dapagliflozin 5 mg + Background Anti-Diabetes Medication Dapagliflozin tablets, oral, once daily, 12 weeks
Overall Study STARTED	21	23
Overall Study COMPLETED	20	22
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo + Background Anti-Diabetes Medication Placebo tablets, oral, once daily, 12 weeks	Dapagliflozin 5 mg + Background Anti-Diabetes Medication Dapagliflozin tablets, oral, once daily, 12 weeks
Overall Study Lost to Follow-up	1	0
Overall Study No longer met criteria	0	1

Baseline Characteristics

Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + Background Anti-Diabetes Medication n=21 Participants Placebo tablets, oral, once daily, 12 weeks	Dapagliflozin 5 mg + Background Anti-Diabetes Medication n=23 Participants Dapagliflozin tablets, oral, once daily, 12 weeks	Total n=44 Participants Total of all reporting groups
Age, Continuous	53.3 Years STANDARD_DEVIATION 8.02 • n=5 Participants	56.2 Years STANDARD_DEVIATION 8.85 • n=7 Participants	54.8 Years STANDARD_DEVIATION 8.49 • n=5 Participants
Age, Customized Younger than 65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Age, Customized 65-70 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex/Gender, Customized Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex/Gender, Customized Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 12

Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)

Outcome measures

Outcome measures
Measure	Placebo + Background Anti-Diabetes Medication n=19 Participants Placebo tablets, oral, once daily, 12 weeks	Dapagliflozin 5 mg + Background Anti-Diabetes Medication n=22 Participants Dapagliflozin tablets, oral, once daily, 12 weeks
Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])	-9.99 % Change of Baseline Insulin Sensitivity Standard Error 4.0392	7.98 % Change of Baseline Insulin Sensitivity Standard Error 4.4849

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)

Outcome measures

Outcome measures
Measure	Placebo + Background Anti-Diabetes Medication n=19 Participants Placebo tablets, oral, once daily, 12 weeks	Dapagliflozin 5 mg + Background Anti-Diabetes Medication n=23 Participants Dapagliflozin tablets, oral, once daily, 12 weeks
Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])	-12.73 mU/L*min Standard Error 10.7107	15.39 mU/L*min Standard Error 9.5930

Adverse Events

Placebo + Background Anti-Diabetes Medication

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Dapagliflozin 5 mg + Background Anti-Diabetes Medication

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo + Background Anti-Diabetes Medication n=21 participants at risk Placebo tablets, oral, once daily, 12 weeks	Dapagliflozin 5 mg + Background Anti-Diabetes Medication n=23 participants at risk Dapagliflozin tablets, oral, once daily, 12 weeks
Nervous system disorders HEADACHE	14.3% 3/21 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	13.0% 3/23 • Number of events 4 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
General disorders INFUSION SITE PAIN	4.8% 1/21 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	8.7% 2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Renal and urinary disorders MICTURITION URGENCY	0.00% 0/21 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	8.7% 2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Renal and urinary disorders POLLAKIURIA	4.8% 1/21 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	8.7% 2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/21 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	8.7% 2/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
General disorders OEDEMA PERIPHERAL	9.5% 2/21 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	4.3% 1/23 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	9.5% 2/21 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	4.3% 1/23 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
General disorders PYREXIA	14.3% 3/21 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/23 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.

Additional Information

Anna Maria Langkilde

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place