Trial Outcomes & Findings for Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes (NCT NCT00998335)

NCT ID: NCT00998335

Last Updated: 2016-09-28

Results Overview

Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 and 6 months
• Results posted on: 2016-09-28

Participant Flow

Clinical Research Unit

All participants started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio to either Insulin detemir only arm or to Insulin detemir plus aspart.

Participant milestones

Measure	Insulin Detemir Only Patients with uncontrolled T2DM are treated with insulin detemir for 6 months Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.	Insulin Detemir Plus Aspart After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Initial Treatment (Months 0 - 3) STARTED	30	0
Initial Treatment (Months 0 - 3) COMPLETED	30	0
Initial Treatment (Months 0 - 3) NOT COMPLETED	0	0
Randomized Period (Months 3 to 6) STARTED	8	22
Randomized Period (Months 3 to 6) COMPLETED	8	20
Randomized Period (Months 3 to 6) NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Insulin Detemir Only Patients with uncontrolled T2DM are treated with insulin detemir for 6 months Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.	Insulin Detemir Plus Aspart After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Randomized Period (Months 3 to 6) Withdrawal by Subject	0	2

Baseline Characteristics

Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes

Baseline characteristics by cohort

Measure	Insulin Detemir Only n=8 Participants Patients with uncontrolled T2DM are treated with insulin detemir for 6 months Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	22 Participants n=4 Participants	30 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	50 years STANDARD_DEVIATION 8 • n=93 Participants	59 years STANDARD_DEVIATION 8 • n=4 Participants	57 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	19 Participants n=4 Participants	27 Participants n=27 Participants
Region of Enrollment United States	8 participants n=93 Participants	22 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 and 6 months

Population: In six patients liver MRS was not possible due to claustrophobia, metal parts, or too large for MRI scanner. N=30 participants in the Insulin detemir x 3 months, N=8 participants in the Insulin Detemir alone and 22 in the Detemir Plus Aspart at 6 months.

Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Hepatic Steatosis Month 3	6.7 percentage of liver fat Standard Deviation 4.4	NA percentage of liver fat Standard Deviation NA Participants were only randomized to this arm after 3 months of treatment.
Hepatic Steatosis Month 6	8.4 percentage of liver fat Standard Deviation 7.2	5.9 percentage of liver fat Standard Deviation 4.2

SECONDARY outcome

Timeframe: 3 and 6 months

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms.

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Metabolic Control as Measured by the A1c 3-month - A1c	7.4 percentage of A1c Standard Deviation 1.4	NA percentage of A1c Standard Deviation NA Participants were not randomized into this arm until month 3.
Metabolic Control as Measured by the A1c 6-month - A1c	6.9 percentage of A1c Standard Deviation 0.5	6.7 percentage of A1c Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3 and 6 months.

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 at 3 months and N=28 at 6 months.

Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase).

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Change in Insulin Secretion 3-month C-peptide level increase in first phase	0.5 ng/ml Standard Deviation 1.3	NA ng/ml Standard Deviation NA Participants were not randomized to this arm until month 3.
Change in Insulin Secretion 3-month C-peptide level increase in second phase	1.6 ng/ml Standard Deviation 2.5	NA ng/ml Standard Deviation NA Participants were not randomized to this arm until month 3.
Change in Insulin Secretion 6-month C-peptide level increase in first phase	-0.1 ng/ml Standard Deviation 0.9	0.2 ng/ml Standard Deviation 1.4
Change in Insulin Secretion 6-month C-peptide level increase in second phase	0.6 ng/ml Standard Deviation 2.0	0.2 ng/ml Standard Deviation 2.3

SECONDARY outcome

Timeframe: 3 and 6 months.

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months

Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS).

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS). 6-month intramyocellular triglycerides	1.05 % of intramyocellular triglyceride Standard Deviation 0.18	0.49 % of intramyocellular triglyceride Standard Deviation 0.47
Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS). 3-month intramyocellular triglycerides	0.63 % of intramyocellular triglyceride Standard Deviation 0.62	NA % of intramyocellular triglyceride Standard Deviation NA Participants were not randomized to this arm until month 3.

SECONDARY outcome

Timeframe: 3 and 6 months.

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months

Fasting plasma lipid concentration on day of admission at 3 and 6 months.

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Plasma Lipid Concentration. 3-month total cholesterol	136 mg/dL Standard Deviation 36	NA mg/dL Standard Deviation NA Participants were not randomized to this arm until month 3.
Plasma Lipid Concentration. 3-month LDL-cholesterol	76 mg/dL Standard Deviation 27	NA mg/dL Standard Deviation NA Participants were not randomized to this arm until month 3.
Plasma Lipid Concentration. 3-month triglycerides	154 mg/dL Standard Deviation 76	NA mg/dL Standard Deviation NA Participants were not randomized to this arm until month 3.
Plasma Lipid Concentration. 3-month HDL-C	33 mg/dL Standard Deviation 8	NA mg/dL Standard Deviation NA Participants were not randomized to this arm until month 3.
Plasma Lipid Concentration. 6-month total cholesterol	147 mg/dL Standard Deviation 31	145 mg/dL Standard Deviation 37
Plasma Lipid Concentration. 6-month LDL-cholesterol	86 mg/dL Standard Deviation 29	80 mg/dL Standard Deviation 28
Plasma Lipid Concentration. 6-month triglycerides	150 mg/dL Standard Deviation 66	144 mg/dL Standard Deviation 62
Plasma Lipid Concentration. 6-month HDL-C	31 mg/dL Standard Deviation 5	33 mg/dL Standard Deviation 7

SECONDARY outcome

Timeframe: 3 and 6 months.

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months

Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months.

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Change in Anthropometric Measure (Body Weight). 3-month total body weight	-0.8 Change from baseline (Kg) Standard Deviation 7.3	NA Change from baseline (Kg) Standard Deviation NA Participants were not randomized to this arm until month 3.
Change in Anthropometric Measure (Body Weight). 6-month total body weight	0.8 Change from baseline (Kg) Standard Deviation 1.9	0.3 Change from baseline (Kg) Standard Deviation 3.5

SECONDARY outcome

Timeframe: 3 and 6 months

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months

Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial.

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Number of Hypoglycemic Events 3-month rate of severe hypoglycemia	0 Number of events	NA Number of events Participants were not randomized to this arm until month 3.
Number of Hypoglycemic Events 6-month rate of severe hypoglycemia	0 Number of events	0 Number of events

SECONDARY outcome

Timeframe: 3 and 6 months

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Metabolic Control as Measured by the Fasting Plasma Glucose Concentration 3-month - Fasting plasma glucose	105 mg/dL Standard Deviation 38	NA mg/dL Standard Deviation NA Participants were not randomized to this arm until month 3.
Metabolic Control as Measured by the Fasting Plasma Glucose Concentration 6-month - Fasting plasma glucose	89 mg/dL Standard Deviation 18	116 mg/dL Standard Deviation 27

SECONDARY outcome

Timeframe: 3 and 6 months

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile. 3-month - Day-long plasma glucose profile	168 mg/dL Standard Deviation 44	NA mg/dL Standard Deviation NA Participants were not randomized until month 3
Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile. 6-month - Day-long plasma glucose profile	153 mg/dL Standard Deviation 38	170 mg/dL Standard Deviation 48

SECONDARY outcome

Timeframe: 3 and 6 months

Change in lipoprotein particle number was determined using NMR.

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Advanced Lipid Testing VLDL particles (3 months)	-15 Change in number of particles (nmol/L) Standard Deviation 39	NA Change in number of particles (nmol/L) Standard Deviation NA Randomization of this group occurred at month 3.
Advanced Lipid Testing VLDL particles (6 months)	-5 Change in number of particles (nmol/L) Standard Deviation 38	-2 Change in number of particles (nmol/L) Standard Deviation 31
Advanced Lipid Testing LDL particles (3 months)	-100 Change in number of particles (nmol/L) Standard Deviation 313	NA Change in number of particles (nmol/L) Standard Deviation NA Randomization of this group occurred at month 3.
Advanced Lipid Testing LDL particles (6 months)	128 Change in number of particles (nmol/L) Standard Deviation 206	85 Change in number of particles (nmol/L) Standard Deviation 209
Advanced Lipid Testing HDL particles (3 months)	0 Change in number of particles (nmol/L) Standard Deviation 3	NA Change in number of particles (nmol/L) Standard Deviation NA Randomization of this group occurred at month 3.
Advanced Lipid Testing HDL particles (6 months)	2 Change in number of particles (nmol/L) Standard Deviation 4	1 Change in number of particles (nmol/L) Standard Deviation 4

SECONDARY outcome

Timeframe: 3 and 6 months.

Population: All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months

Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months.

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Change in Anthropometric Measure (Body Mass Index [BMI]). 3-month body mass index	-0.4 Change from baseline (Kg/m2) Standard Deviation 2.7	NA Change from baseline (Kg/m2) Standard Deviation NA Patients were not randomized to this arm until month 3.
Change in Anthropometric Measure (Body Mass Index [BMI]). 6-month body mass index	0.3 Change from baseline (Kg/m2) Standard Deviation 0.6	0.2 Change from baseline (Kg/m2) Standard Deviation 1.2

SECONDARY outcome

Timeframe: 3 and 6 months

Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM

Outcome measures

Measure	Insulin Detemir x 3 Months (All Pts Had Liver MRS) n=30 Participants Liver fat by MRS measured after 3 months of insulin.	Insulin Detemir Plus Aspart n=22 Participants After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2. Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.
Percent Change From Baseline in Vascular Inflammatory Markers Adiponectin (3 months)	18 Percentage of change Standard Deviation 63	NA Percentage of change Standard Deviation NA Patients were not randomized to this arm until month 3.
Percent Change From Baseline in Vascular Inflammatory Markers Adiponectin (6 months)	65 Percentage of change Standard Deviation 71	5 Percentage of change Standard Deviation 30
Percent Change From Baseline in Vascular Inflammatory Markers MMP-9 (3 months)	32 Percentage of change Standard Deviation 59	NA Percentage of change Standard Deviation NA Patients were not randomized to this arm until month 3.
Percent Change From Baseline in Vascular Inflammatory Markers MMP-9 (6 months)	30 Percentage of change Standard Deviation 115	49 Percentage of change Standard Deviation 73
Percent Change From Baseline in Vascular Inflammatory Markers E-selectin (3 months)	-6 Percentage of change Standard Deviation 25	NA Percentage of change Standard Deviation NA Patients were not randomized to this arm until month 3.
Percent Change From Baseline in Vascular Inflammatory Markers E-selectin (6 months)	34 Percentage of change Standard Deviation 34	19 Percentage of change Standard Deviation 29
Percent Change From Baseline in Vascular Inflammatory Markers sICAM (3 months)	-4 Percentage of change Standard Deviation 22	NA Percentage of change Standard Deviation NA Patients were not randomized to this arm until month 3.
Percent Change From Baseline in Vascular Inflammatory Markers sICAM (6 months)	2 Percentage of change Standard Deviation 12	-1 Percentage of change Standard Deviation 15
Percent Change From Baseline in Vascular Inflammatory Markers sVCAM (3 months)	1 Percentage of change Standard Deviation 8	NA Percentage of change Standard Deviation NA Patients were not randomized to this arm until month 3.
Percent Change From Baseline in Vascular Inflammatory Markers sVCAM (6 months)	14 Percentage of change Standard Deviation 13	7 Percentage of change Standard Deviation 11

Adverse Events

Insulin Detemir Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Detemir Plus Aspart

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

Dr. Kenneth Cusi

University of Florida

Phone: 352-273-7236

Email: KCusi@ufl.edu

Results disclosure agreements

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