Trial Outcomes & Findings for Preferred Treatment of Type 1.5 Diabetes (NCT NCT00194896)
NCT ID: NCT00194896
Last Updated: 2018-03-29
Results Overview
Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
36 months
Results posted on
2018-03-29
Participant Flow
Recruited through endocrinology physicians.
Participant milestones
| Measure |
Rosiglitazone Autoantibody Positive
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
|
Rosiglitazone Autoantibody Negative
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Positive
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Negative
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
13
|
21
|
|
Overall Study
COMPLETED
|
4
|
10
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
6
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preferred Treatment of Type 1.5 Diabetes
Baseline characteristics by cohort
| Measure |
Rosiglitazone Autoantibody Positive
n=15 Participants
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
|
Rosiglitazone Autoantibody Negative
n=15 Participants
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Positive
n=13 Participants
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Negative
n=21 Participants
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
Total
n=64 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Continuous
|
55.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 9 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
55.8 years
STANDARD_DEVIATION 1.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
13 participants
n=5 Participants
|
21 participants
n=4 Participants
|
64 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Analysis per protocol
Changes in beta cell function assessed by fasting and stimulated C-peptide measured at 36 months.
Outcome measures
| Measure |
Rosiglitazone Autoantibody Positive
n=15 Participants
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
|
Rosiglitazone Autoantibody Negative
n=15 Participants
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Positive
n=13 Participants
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Negative
n=21 Participants
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
|---|---|---|---|---|
|
Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.
Fasting C-peptide
|
-0.4 ng per ml
Standard Deviation 1.0
|
-1.4 ng per ml
Standard Deviation 1.6
|
0.1 ng per ml
Standard Deviation 1.2
|
0.3 ng per ml
Standard Deviation 1.1
|
|
Changes in Beta Cell Function Assessed by Fasting and Stimulated C-peptide Measured at 36 Months.
Glucagon Stimulated C-peptide
|
-0.6 ng per ml
Standard Deviation 1.6
|
-2.8 ng per ml
Standard Deviation 2.5
|
3.1 ng per ml
Standard Deviation 12.1
|
0.3 ng per ml
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 36 monthsNumber of participants positive for T cell reactivity to islet proteins at 36 months.
Outcome measures
| Measure |
Rosiglitazone Autoantibody Positive
n=4 Participants
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
|
Rosiglitazone Autoantibody Negative
n=10 Participants
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Positive
n=7 Participants
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Negative
n=9 Participants
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
|---|---|---|---|---|
|
Patients Positive for T Cell Responses to Islet Proteins at 36 Months.
|
1 participants
0
|
2 participants
0
|
2 participants
0
|
3 participants
0
|
Adverse Events
Rosiglitazone Autoantibody Positive
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Rosiglitazone Autoantibody Negative
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Glyburide Autoantibody Positive
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Glyburide Autoantibody Negative
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosiglitazone Autoantibody Positive
n=15 participants at risk
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
|
Rosiglitazone Autoantibody Negative
n=15 participants at risk
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Positive
n=13 participants at risk
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Negative
n=21 participants at risk
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
|---|---|---|---|---|
|
General disorders
Death
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/13 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/21 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
|
Endocrine disorders
Cholecystitis
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/13 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/21 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/13 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/21 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
|
Vascular disorders
Stroke
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/13 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
9.5%
2/21 • Number of events 2 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/13 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
4.8%
1/21 • Number of events 1 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
Other adverse events
| Measure |
Rosiglitazone Autoantibody Positive
n=15 participants at risk
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
|
Rosiglitazone Autoantibody Negative
n=15 participants at risk
Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Positive
n=13 participants at risk
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
|
Glyburide Autoantibody Negative
n=21 participants at risk
Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
|
|---|---|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
0.00%
0/15 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
4.8%
1/21 • Number of events 1 • Adverse event data was collected during the period the research subjects were actively participating in the study. This time period was between February 3, 2000 through September 8, 2008.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place