Trial Outcomes & Findings for Insulin Glargine at Bedtime or in AM Versus NPH (NCT NCT00686712)

NCT ID: NCT00686712

Last Updated: 2017-05-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 108 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2017-05-22

Participant Flow

Recruitment occurred from Sep 2002 to Feb 2009. 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. 23 subjects not randomized due to protocol violations, loss to follow-up, lack of need for insulin, or voluntarily.

Participant milestones

Measure	Insulin Glargine at Bedtime Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin Bedtime NPH insulin titrated to morning fasting glucose readings
Overall Study STARTED	30	25	30
Overall Study COMPLETED	20	14	17
Overall Study NOT COMPLETED	10	11	13

Reasons for withdrawal

Measure	Insulin Glargine at Bedtime Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin Bedtime NPH insulin titrated to morning fasting glucose readings
Overall Study Protocol Violation	8	8	10
Overall Study Lost to Follow-up	1	2	3
Overall Study Adverse Event	1	1	0

Baseline Characteristics

Insulin Glargine at Bedtime or in AM Versus NPH

Baseline characteristics by cohort

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings	Total n=85 Participants Total of all reporting groups
Age, Continuous	50.3 years STANDARD_DEVIATION 11.2 • n=5 Participants	53.0 years STANDARD_DEVIATION 8.6 • n=7 Participants	53.2 years STANDARD_DEVIATION 7.7 • n=5 Participants	52.1 years STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	36 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	24 participants n=5 Participants	21 participants n=7 Participants	25 participants n=5 Participants	70 participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	15 participants n=4 Participants
Hemoglobin A1c	9.2 Percent STANDARD_DEVIATION 1.3 • n=5 Participants	9.6 Percent STANDARD_DEVIATION 1.2 • n=7 Participants	9.3 Percent STANDARD_DEVIATION 1.6 • n=5 Participants	9.3 Percent STANDARD_DEVIATION 1.4 • n=4 Participants
Diabetes Duration	9.0 Years STANDARD_DEVIATION 5.9 • n=5 Participants	9.5 Years STANDARD_DEVIATION 5.2 • n=7 Participants	7.8 Years STANDARD_DEVIATION 4.2 • n=5 Participants	8.7 Years STANDARD_DEVIATION 5.1 • n=4 Participants
Body Mass Index	31.6 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants	31.1 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	32.1 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants	31.6 kg/m^2 STANDARD_DEVIATION 5.4 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: ITT (LOCF)

Outcome measures

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings
Hemoglobin A1c Change From Baseline	-1.3 Percent Standard Deviation 1.2	-1.9 Percent Standard Deviation 1.4	-1.4 Percent Standard Deviation 1.7

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled subjects

Frequency of glucose readings below the recommended pre-meal glucose target of 130 mg/dL

Outcome measures

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings
Frequency of Glucose Readings < 130 mg/dL	61.7 percentage of readings Standard Deviation 22.8	73.0 percentage of readings Standard Deviation 25.1	72.6 percentage of readings Standard Deviation 22.7

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled subjects

Frequency of hypoglycemic reactions without regard to time of occurrence

Outcome measures

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings
Frequency of Total Hypoglycemic Reactions	6.7 Hypoglycemic events per patient Standard Deviation 9.6	9.6 Hypoglycemic events per patient Standard Deviation 6.6	8.2 Hypoglycemic events per patient Standard Deviation 8.7

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled subjects

Frequency of severe hypoglycemic reactions, defined as those requiring the assistance of another person

Outcome measures

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings
Frequency of Severe Hypoglycemic Reactions	0 Severe hypoglycemic events	0 Severe hypoglycemic events	0 Severe hypoglycemic events

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled subjects

Change in body mass index from baseline BMI measurement

Outcome measures

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings
Body Mass Index Change From Baseline	0.7 kg per square meter Standard Deviation 1.6	1.1 kg per square meter Standard Deviation 1.4	0.0 kg per square meter Standard Deviation 1.5

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled subjects

Total daily number of units of insulin used

Outcome measures

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings
Total Daily Insulin Dose	17.7 Units of insulin per day Standard Deviation 10.1	17.9 Units of insulin per day Standard Deviation 14.4	14.6 Units of insulin per day Standard Deviation 13.4

SECONDARY outcome

Timeframe: 6 months

Population: Enrolled subjects

Any reported adverse event that is not hypoglycemia

Outcome measures

Measure	Insulin Glargine at Bedtime n=30 Participants Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 Participants Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 Participants Bedtime NPH insulin titrated to morning fasting glucose readings
Any Adverse Event Other Than Hypoglycemia	1 Events	2 Events	1 Events

Adverse Events

Insulin Glargine at Bedtime

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Insulin Glargine in AM

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

NPH Insulin

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Insulin Glargine at Bedtime n=30 participants at risk Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 participants at risk Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 participants at risk Bedtime NPH insulin titrated to morning fasting glucose readings
Infections and infestations Foot Infection (Hospitalization)	0.00% 0/30 • 6 months	4.0% 1/25 • Number of events 2 • 6 months	0.00% 0/30 • 6 months

Other adverse events

Measure	Insulin Glargine at Bedtime n=30 participants at risk Bedtime insulin glargine titrated to morning fasting glucose readings	Insulin Glargine in AM n=25 participants at risk Morning insulin glargine titrated to pre-supper glucose readings	NPH Insulin n=30 participants at risk Bedtime NPH insulin titrated to morning fasting glucose readings
Endocrine disorders Symptomatic Hypoglycemia	76.7% 23/30 • Number of events 200 • 6 months	96.0% 24/25 • Number of events 239 • 6 months	76.7% 23/30 • Number of events 247 • 6 months
Eye disorders Asymptomatic Retinal Hemorrhage	3.3% 1/30 • Number of events 1 • 6 months	0.00% 0/25 • 6 months	0.00% 0/30 • 6 months
Infections and infestations Urinary Tract Infection	0.00% 0/30 • 6 months	0.00% 0/25 • 6 months	3.3% 1/30 • Number of events 1 • 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