Trial Outcomes & Findings for Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial) (NCT NCT01181674)
NCT ID: NCT01181674
Last Updated: 2020-05-21
Results Overview
1. Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group. 2. Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group. Normoglycemia on therapy is defined as a mean fasting capillary blood glucose \</=5.4 mmol/L and a mean 2-hour pc blood glucose \</=6.8 mmol/L on 2 seven-point glucose profiles.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
83 participants
Primary outcome timeframe
(1) 8 weeks and (2) 16 weeks
Results posted on
2020-05-21
Participant Flow
Participant milestones
| Measure |
Group 1 (Short)
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)
Baseline characteristics by cohort
| Measure |
Group 1 (Short)
n=28 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=27 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=28 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
28 participants
n=5 Participants
|
83 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: (1) 8 weeks and (2) 16 weeksPopulation: Primary outcome (1) is reported in Experimental Group 1 and Standard care at 8 weeks. Primary outcome (2) is reported in experimental Group 2 and Standard care at 16 weeks.
1. Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group. 2. Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group. Normoglycemia on therapy is defined as a mean fasting capillary blood glucose \</=5.4 mmol/L and a mean 2-hour pc blood glucose \</=6.8 mmol/L on 2 seven-point glucose profiles.
Outcome measures
| Measure |
Group 1 (Short)
n=28 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=27 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=28 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
Normoglycemia on Therapy
Group 1 and Standard care at 8 weeks
|
14 Participants
|
—
|
1 Participants
|
|
Normoglycemia on Therapy
Group 2 and Standard care at 16 weeks
|
—
|
19 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: (1) 20 weeks and (2) 28 weeksPopulation: Outcome (1) is reported in Experimental Group 1 and Standard care at 20 weeks. Outcome (2) is reported in experimental Group 2 and Standard care at 28 weeks.
Normal glucose tolerance is defined as a fasting plasma glucose \<6.1 mmol/L and a 2-hour pc plasma glucose \<7.8 mmol/L on a 75 g oral glucose tolerance test off diabetes drugs.
Outcome measures
| Measure |
Group 1 (Short)
n=28 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=27 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=28 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.
Group 1 and Standard care at 20 weeks
|
2 Participants
|
—
|
2 Participants
|
|
1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.
Group 2 and Standard care at 28 weeks
|
—
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 52 weeksNormal fasting plasma glucose is defined as \<6.1 mmol/L.
Outcome measures
| Measure |
Group 1 (Short)
n=23 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=23 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=25 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
Percentage of Participants With Normal Fasting Plasma Glucose
|
5 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 52 weeksPopulation: FPG was not available for some participants at 52 weeks.
Outcome measures
| Measure |
Group 1 (Short)
n=23 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=23 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=25 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline
|
-0.23 mmol/L
Standard Deviation 0.96
|
-0.64 mmol/L
Standard Deviation 1.38
|
0.05 mmol/L
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 8, 20, 28 and 52 weeksPopulation: Some participants did not provide HbA1C values.
Outcome measures
| Measure |
Group 1 (Short)
n=24 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=23 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=25 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
HbA1C
8 weeks
|
6.1 percent
Standard Deviation 0.5
|
6.0 percent
Standard Deviation 0.4
|
6.6 percent
Standard Deviation 0.7
|
|
HbA1C
20 weeks
|
6.2 percent
Standard Deviation 0.4
|
6.1 percent
Standard Deviation 0.3
|
6.6 percent
Standard Deviation 0.7
|
|
HbA1C
28 weeks
|
6.5 percent
Standard Deviation 0.8
|
6.4 percent
Standard Deviation 0.5
|
6.6 percent
Standard Deviation 0.7
|
|
HbA1C
52 weeks
|
6.4 percent
Standard Deviation 0.8
|
6.7 percent
Standard Deviation 0.7
|
6.5 percent
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline, 8, 20, 28 and 52 weeksOutcome measures
| Measure |
Group 1 (Short)
n=23 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=22 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=25 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
Change in Weight From Baseline
Baseline
|
99.5 kg
Standard Deviation 23.3
|
95.3 kg
Standard Deviation 15.2
|
89.3 kg
Standard Deviation 14.6
|
|
Change in Weight From Baseline
8 weeks
|
95.3 kg
Standard Deviation 21.8
|
92.4 kg
Standard Deviation 15.0
|
87.1 kg
Standard Deviation 14.1
|
|
Change in Weight From Baseline
20 weeks
|
92.8 kg
Standard Deviation 21.1
|
90.5 kg
Standard Deviation 14.8
|
86.3 kg
Standard Deviation 13.5
|
|
Change in Weight From Baseline
28 weeks
|
93.3 kg
Standard Deviation 20.6
|
91.7 kg
Standard Deviation 15.2
|
86.1 kg
Standard Deviation 13.5
|
|
Change in Weight From Baseline
52 weeks
|
96.6 kg
Standard Deviation 21.7
|
93.8 kg
Standard Deviation 16.4
|
86.5 kg
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: 52 weeksOutcome measures
| Measure |
Group 1 (Short)
n=28 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=27 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=28 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
Number of Participants With Symptomatic Hypoglycemic Episodes
|
9 Participants
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 52 weeksOutcome measures
| Measure |
Group 1 (Short)
n=28 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=27 Participants
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=28 Participants
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
Number of Participants With Severe Hypoglycemic Episodes
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1 (Short)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 (Long)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Short)
n=28 participants at risk
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Group 2 (Long)
n=27 participants at risk
insulin glargine: sc injection
metformin: oral administration
acarbose: oral administration
lifestyle therapy: diet and exercise
|
Standard Care
n=28 participants at risk
Standard glycemic care: as informed by the current clinical practice guidelines
|
|---|---|---|---|
|
General disorders
Chest pain
|
7.1%
2/28 • Number of events 2 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
0.00%
0/28 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
3.6%
1/28 • Number of events 1 • 52 weeks
|
3.7%
1/27 • Number of events 1 • 52 weeks
|
10.7%
3/28 • Number of events 3 • 52 weeks
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.00%
0/28 • 52 weeks
|
0.00%
0/27 • 52 weeks
|
7.1%
2/28 • Number of events 2 • 52 weeks
|
Additional Information
Dr. Natalia McInnes (nee Yakubovich)
McMaster University
Phone: 905-521-2100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place