Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow:   Overall Study

	Insulin Glargine at Bedtime	Insulin Glargine in AM	NPH Insulin
STARTED	30	25	30
COMPLETED	20	14	17
NOT COMPLETED	10	11	13
Protocol Violation	8	8	10
Lost to Follow-up	1	2	3
Adverse Event	1	1	0

Reporting Groups

	Description
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

Baseline Measures

	Insulin Glargine at Bedtime	Insulin Glargine in AM	NPH Insulin	Total
Number of Participants   [units: participants]	30	25	30	85
Age   [units: years] Mean ± Standard Deviation	50.3  ± 11.2	53.0  ± 8.6	53.2  ± 7.7	52.1  ± 9.3
Gender   [units: participants]
Female	15	13	21	49
Male	15	12	9	36
Ethnicity (NIH/OMB)   [units: participants]
Hispanic or Latino	24	21	25	70
African-American	5	3	4	12
Other	1	1	1	3
Hemoglobin A1c   [units: %] Mean ± Standard Deviation	9.2  ± 1.3	9.6  ± 1.2	9.3  ± 1.6	9.3  ± 1.4
Diabetes Duration   [units: Years] Mean ± Standard Deviation	9.0  ± 5.9	9.5  ± 5.2	7.8  ± 4.2	8.7  ± 5.1
Body Mass Index   [units: kg/m2] Mean ± Standard Deviation	31.6  ± 5.0	31.1  ± 5.2	32.1  ± 6.0	31.6  ± 5.4

1.  Primary:

Hemoglobin A1c Change From Baseline   [ Time Frame: 6 months ]

2.  Secondary:

Frequency of Glucose Readings < 130 mg/dL   [ Time Frame: 6 months ]

3.  Secondary:

Frequency of Total Hypoglycemic Reactions   [ Time Frame: 6 months ]

4.  Secondary:

Frequency of Severe Hypoglycemic Reactions   [ Time Frame: 6 months ]

5.  Secondary:

Body Mass Index Change From Baseline   [ Time Frame: 6 months ]

6.  Secondary:

Total Daily Insulin Dose   [ Time Frame: 6 months ]

7.  Secondary:

Any Adverse Event Other Than Hypoglycemia   [ Time Frame: 6 months ]