Trial Outcomes & Findings for Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH (NCT NCT00564018)

Last Updated: 2019-10-11

Results Overview

We measured the insulin secretory capacity of the pancreas by measuring C-peptide levels (and calculating the C-peptide area under the curve (AUC) using the trapezoidal method following a mixed meal tolerance test (using Boost) at 1, 6 and 12 months after diagnosis.

Recruitment status

TERMINATED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis

Results posted on

2019-10-11

Participant Flow

Participant milestones

Participant milestones
Measure	Detemir Subjects randomized to treatment with insulins detemir and aspart	NPH Insulin Subjects randomized to treatment with insulins NPH and aspart	Glargine Subjects randomized to treatment with insulins glargine and aspart
Overall Study STARTED	11	10	12
Overall Study COMPLETED	9	7	11
Overall Study NOT COMPLETED	2	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Detemir Subjects randomized to treatment with insulins detemir and aspart	NPH Insulin Subjects randomized to treatment with insulins NPH and aspart	Glargine Subjects randomized to treatment with insulins glargine and aspart
Overall Study Withdrawal by Subject	2	3	1

Baseline Characteristics

Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Detemir n=11 Participants Subjects randomized to treatment with insulins detemir and aspart	Isophane (NPH) Insulin n=10 Participants Subjects randomized to treatment with insulins NPH and aspart	Glargine n=12 Participants Subjects randomized to treatment with insulins glargine and aspart	Total n=33 Participants Total of all reporting groups
Age, Continuous	10.1 years STANDARD_DEVIATION 3.0 • n=10 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	11.0 years STANDARD_DEVIATION 1.6 • n=8 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	9.9 years STANDARD_DEVIATION 2.5 • n=11 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	10.3 years STANDARD_DEVIATION 3.0 • n=29 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.
Sex: Female, Male Female	4 Participants n=11 Participants	6 Participants n=10 Participants	9 Participants n=12 Participants	19 Participants n=33 Participants
Sex: Female, Male Male	7 Participants n=11 Participants	4 Participants n=10 Participants	3 Participants n=12 Participants	14 Participants n=33 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Asian	1 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	1 Participants n=33 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Black or African American	1 Participants n=11 Participants	3 Participants n=10 Participants	2 Participants n=12 Participants	6 Participants n=33 Participants
Race (NIH/OMB) White	9 Participants n=11 Participants	7 Participants n=10 Participants	10 Participants n=12 Participants	26 Participants n=33 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=33 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants	0 Participants n=10 Participants	0 Participants n=12 Participants	0 Participants n=33 Participants
Region of Enrollment United States	11 participants n=11 Participants	10 participants n=10 Participants	12 participants n=12 Participants	33 participants n=33 Participants
Hemoglobin A1c (percent)	11.9 percent STANDARD_DEVIATION 1.7 • n=10 Participants • Subjects were enrolled immediately after diagnosis of diabetes. Subjects who then were antibody (-) for type 1 diabetes associated antibodies are excluded from the baseline data reported.	12.6 percent STANDARD_DEVIATION 1.7 • n=8 Participants • Subjects were enrolled immediately after diagnosis of diabetes. Subjects who then were antibody (-) for type 1 diabetes associated antibodies are excluded from the baseline data reported.	12.1 percent STANDARD_DEVIATION 1.8 • n=11 Participants • Subjects were enrolled immediately after diagnosis of diabetes. Subjects who then were antibody (-) for type 1 diabetes associated antibodies are excluded from the baseline data reported.	12.2 percent STANDARD_DEVIATION 1.7 • n=29 Participants • Subjects were enrolled immediately after diagnosis of diabetes. Subjects who then were antibody (-) for type 1 diabetes associated antibodies are excluded from the baseline data reported.
Bicarbonate (HCO3) (meq/L)	21.0 meQ/L STANDARD_DEVIATION 4.7 • n=10 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	15.6 meQ/L STANDARD_DEVIATION 6.1 • n=8 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	14.9 meQ/L STANDARD_DEVIATION 8.1 • n=11 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	17.3 meQ/L STANDARD_DEVIATION 6.8 • n=29 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.
Beta Hydroxy Butyrate (mmol/L)	4.7 mmol/L STANDARD_DEVIATION 2.6 • n=10 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	3.9 mmol/L STANDARD_DEVIATION 3.5 • n=8 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	7.9 mmol/L STANDARD_DEVIATION 4.0 • n=11 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	5.5 mmol/L STANDARD_DEVIATION 3.6 • n=29 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.
Total Daily Dose of Insulin (Units/kg/day)	0.70 Units/kg/day STANDARD_DEVIATION 0.11 • n=10 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	0.69 Units/kg/day STANDARD_DEVIATION 0.12 • n=8 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	0.75 Units/kg/day STANDARD_DEVIATION 0.14 • n=11 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.	0.70 Units/kg/day STANDARD_DEVIATION 0.10 • n=29 Participants • Subjects were recruited immediately after diagnosis of diabetes. Subjects who then tested (-) for type 1 diabetes associated antibodies were excluded from further analyses.

PRIMARY outcome

Timeframe: Although measured at 1, 6 and 12 months, the primary outcomes was a comparison between treatment groups at 6 months after diagnosis

Population: All subjects who completed 6 month mixed meal tolerance test (MMTT)s

Outcome measures

Outcome measures
Measure	Detemir n=10 Participants Subjects randomized to treatment with insulins detemir and aspart	NPH Insulin n=7 Participants Subjects randomized to treatment with insulins NPH and aspart	Glargine n=10 Participants Subjects randomized to treatment with insulins glargine and aspart
C-peptide Area Under the Curve	220 ng*hr/mL Interval 143.0 to 312.0	144 ng*hr/mL Interval 83.0 to 302.0	51 ng*hr/mL Interval 29.0 to 123.0

SECONDARY outcome

Timeframe: 6 months

Population: Data is presented for each subject at each time for which there was a measure.

We assessed glycemic control via measurement of Hemoglobin A1c at each quarterly clinic visit after diagnosis of diabetes. Data on the 6 month time point are presented

Outcome measures

Outcome measures
Measure	Detemir n=10 Participants Subjects randomized to treatment with insulins detemir and aspart	NPH Insulin n=8 Participants Subjects randomized to treatment with insulins NPH and aspart	Glargine n=11 Participants Subjects randomized to treatment with insulins glargine and aspart
Glycemic Control as Determined by HgbA1c Values at 6 Months After Diagnosis	7.6 percent Standard Deviation 1.3	8.0 percent Standard Deviation 2.0	7.9 percent Standard Deviation 1.2

Adverse Events

Detemir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NPH Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glargine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Soumya Adhikari, MD

UT Southwestern Medical Center

Phone: 214 456 5959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place