Trial Outcomes & Findings for Phase III Insulin Add-On Asia Regional Program - ST (NCT NCT02096705)

NCT ID: NCT02096705

Last Updated: 2017-08-09

Results Overview

The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

477 participants

Primary outcome timeframe

Baseline (Day 1) and 24 weeks

Results posted on

2017-08-09

Participant Flow

477 participants were enrolled; 313 entered lead-in period; 272 participants were randomized to a treatment group. Of the 205 participants not randomized to a treatment group: 190 No longer met study criteria, 11 withdrew consent, 2 were lost to follow-up, and 2 were removed for administrative reasons.

Participant milestones

Participant milestones
Measure	Placebo Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Dapagliflozin Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Treatment STARTED	133	139
Treatment COMPLETED	124	134
Treatment NOT COMPLETED	9	5
Follow-up STARTED	129	139
Follow-up COMPLETED	125	135
Follow-up NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Dapagliflozin Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Treatment Adverse Event	6	3
Treatment Subject request to discontinue treatment	1	1
Treatment Withdrawal by Subject	1	0
Treatment Other	1	1
Follow-up Withdrawal by Subject	1	0
Follow-up Adverse Event	2	2
Follow-up Subjects not reporting status	1	2

Baseline Characteristics

Phase III Insulin Add-On Asia Regional Program - ST

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=133 Participants Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Dapagliflozin n=139 Participants Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin	Total n=272 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	97 Participants n=5 Participants	117 Participants n=7 Participants	214 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	22 Participants n=7 Participants	58 Participants n=5 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 8.91 • n=5 Participants	56.5 years STANDARD_DEVIATION 8.39 • n=7 Participants	57.5 years STANDARD_DEVIATION 8.70 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	73 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	66 Participants n=7 Participants	130 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and 24 weeks

Population: All randomized participants with non-missing baseline and at least one post-baseline value

The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.

Outcome measures

Outcome measures
Measure	Placebo n=129 Participants Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Dapagliflozin n=137 Participants Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Adjusted Mean Change in HbA1c From Baseline to Week 24	0.03 percentage of hemoglobin Standard Error 0.0707	-0.87 percentage of hemoglobin Standard Error 0.0666

SECONDARY outcome

Timeframe: Baseline (Day 1) and 24 weeks

Population: All randomized participants with non-missing baseline and at least one post-baseline value

The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).

Outcome measures

Outcome measures
Measure	Placebo n=133 Participants Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Dapagliflozin n=138 Participants Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24	0.07 mg/dL Standard Error 3.3803	-30.62 mg/dL Standard Error 3.1314

SECONDARY outcome

Timeframe: Baseline (Day 1) and 24 weeks

Population: All randomized participants with non-missing baseline and at least one post-baseline value

Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).

Outcome measures

Outcome measures
Measure	Placebo n=133 Participants Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Dapagliflozin n=138 Participants Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Adjusted Mean Change in Body Weight From Baseline to Week 24	0.37 kilograms Standard Error 0.2224	-1.00 kilograms Standard Error 0.2103

SECONDARY outcome

Timeframe: Baseline (Day 1) and 24 weeks

Population: All randomized participants with non-missing baseline and at least one post-baseline value

The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).

Outcome measures

Outcome measures
Measure	Placebo n=133 Participants Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin	Dapagliflozin n=139 Participants Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24	0.74 International Units (IU) Standard Error 0.3723	-0.70 International Units (IU) Standard Error 0.3592

Adverse Events

Dapagliflozin

Serious events: 8 serious events

Other events: 61 other events

Deaths: 0 deaths

Placebo

Serious events: 18 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Dapagliflozin n=139 participants at risk Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin	Placebo n=133 participants at risk Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
Infections and infestations NASOPHARYNGITIS	3.6% 5/139 • Number of events 6 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.	5.3% 7/133 • Number of events 8 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.8% 8/139 • Number of events 8 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.	6.8% 9/133 • Number of events 12 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.
Infections and infestations URINARY TRACT INFECTION	3.6% 5/139 • Number of events 5 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.	5.3% 7/133 • Number of events 7 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.
Metabolism and nutrition disorders DYSLIPIDAEMIA	6.5% 9/139 • Number of events 9 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.	9.0% 12/133 • Number of events 13 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.
Metabolism and nutrition disorders HYPERLIPIDAEMIA	22.3% 31/139 • Number of events 36 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.	23.3% 31/133 • Number of events 31 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.
Metabolism and nutrition disorders HYPERURICAEMIA	8.6% 12/139 • Number of events 13 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.	9.0% 12/133 • Number of events 15 • 24 week treatment period + 30 days Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.

Additional Information

Anna Maria Langkilde

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER