Trial Outcomes & Findings for Insulin Glargine Versus Twice-Daily NPH (NCT NCT00687453)

NCT ID: NCT00687453

Last Updated: 2023-11-02

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 27 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2023-11-02

Participant Flow

Recruitment from Feb 2003 to Dec 2008. Subjects recruited from a diabetes specialty referral clinic, as well as from primary care clinics and through advertising in the South Los Angeles area.

Baseline run-in period to document baseline control and reinforce dietary/lifestyle principles. 3 subjects not randomized due to protocol violations.

Participant milestones

Measure	Insulin Glargine at Bedtime Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Overall Study STARTED	11	13
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Glargine Versus Twice-Daily NPH

Baseline characteristics by cohort

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively	Total n=24 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 7.0 • n=93 Participants	54.6 years STANDARD_DEVIATION 7.6 • n=4 Participants	55.0 years STANDARD_DEVIATION 7.2 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Hemoglobin A1c	9.1 Percent STANDARD_DEVIATION 1.4 • n=93 Participants	9.5 Percent STANDARD_DEVIATION 1.2 • n=4 Participants	9.3 Percent STANDARD_DEVIATION 1.3 • n=27 Participants
Fasting Plasma Glucose	146 mg/dL STANDARD_DEVIATION 75 • n=93 Participants	145 mg/dL STANDARD_DEVIATION 34 • n=4 Participants	146 mg/dL STANDARD_DEVIATION 56 • n=27 Participants
Diabetes Duration	9.4 Years STANDARD_DEVIATION 3.5 • n=93 Participants	11.5 Years STANDARD_DEVIATION 4.0 • n=4 Participants	10.6 Years STANDARD_DEVIATION 3.8 • n=27 Participants
Body Mass Index	29.9 kg/m^2 STANDARD_DEVIATION 4.1 • n=93 Participants	33.5 kg/m^2 STANDARD_DEVIATION 6.6 • n=4 Participants	31.8 kg/m^2 STANDARD_DEVIATION 5.8 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: ITT (LOCF)

Outcome measures

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Hemoglobin A1c Change From Baseline	-0.8 Percent glycated hemoglobin Standard Deviation 0.9	-1.0 Percent glycated hemoglobin Standard Deviation 1.2

SECONDARY outcome

Timeframe: 6 months

Population: ITT (LOCF)

Outcome measures

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Frequency of Pre-supper Glucose Readings 130 mg/dL or Less, Change From Baseline	38.0 % of readings, change from baseline Standard Deviation 30.1	7.5 % of readings, change from baseline Standard Deviation 22.6

SECONDARY outcome

Timeframe: 6 months

Population: ITT (LOCF)

Outcome measures

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Frequency of Total Hypoglycemic Reactions	55 Events	28 Events

SECONDARY outcome

Timeframe: 6 months

Population: ITT (LOCF)

Outcome measures

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Frequency of Severe Hypoglycemic Reactions	0 Events	0 Events

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT (LOCF)

Outcome measures

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Body Mass Index Change From Baseline	0.2 kg/m^2 Standard Deviation 1.0	0.3 kg/m^2 Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: ITT (LOCF)

Outcome measures

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Total Daily Insulin Dose	-0.1 Units per day, change from baseline Standard Deviation 14.4	20.5 Units per day, change from baseline Standard Deviation 9.8

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Insulin Glargine at Bedtime n=11 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 Participants Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Any Adverse Event Other Than Hypoglycemia	2 Events	1 Events

Adverse Events

Insulin Glargine at Bedtime

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

NPH Twice-daily

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Insulin Glargine at Bedtime n=11 participants at risk Bedtime insulin glargine titrated to morning fasting glucose readings	NPH Twice-daily n=13 participants at risk Morning and bedtime NPH insulin titrated to pre-supper and fasting glucose readings, respectively
Endocrine disorders Symptomatic Hypoglycemia	72.7% 8/11 • Number of events 55 • 6 months	38.5% 5/13 • Number of events 28 • 6 months
Blood and lymphatic system disorders Peripheral Edema	9.1% 1/11 • Number of events 1 • 6 months	0.00% 0/13 • 6 months

Additional Information

Stanley H. Hsia, MD

Charles R. Drew University of Medicine and Science

Phone: 323-357-3633

Email: stanleyhsia@cdrewu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place