Trial Outcomes & Findings for Insulin Glulisine in Type 2 Diabetic Patients (NCT NCT00360698)

Results Overview

Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c \<7%

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

106 participants

Primary outcome timeframe

at the end of treatment (week 24)

Results posted on

2011-08-08

Participant Flow

During Run-In period patients were not assigned to a treatment group. They were all treated with Insulin Glargine + Metformin + Glimepiride.

Participant milestones

Participant milestones
Measure	Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)	Insulin Glargine+Metformin+Glimepiride Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
Run-In STARTED	0	135
Run-In COMPLETED	0	125
Run-In NOT COMPLETED	0	10
Treatment Period STARTED	49	57
Treatment Period COMPLETED	48	56
Treatment Period NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)	Insulin Glargine+Metformin+Glimepiride Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
Run-In Physician Decision	0	1
Run-In Withdrawal by Subject	0	2
Run-In Non compliance with treatment procedure	0	1
Run-In Sponsor request	0	2
Run-In Patient did not meet inclusion criteria	0	1
Run-In Patient personal reasons	0	2
Run-In Need of insulin with meals	0	1
Treatment Period Non compliance with treatment procedure	1	0
Treatment Period Early termination by error	0	1

Baseline Characteristics

Insulin Glulisine in Type 2 Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride n=49 Participants Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)	Insulin Glargine+Metformin+Glimepiride n=57 Participants Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)	Total n=106 Participants Total of all reporting groups
Age Continuous	60.6 years STANDARD_DEVIATION 6.73 • n=5 Participants	59.3 years STANDARD_DEVIATION 8.84 • n=7 Participants	59.9 years STANDARD_DEVIATION 7.92 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	35 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	27 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants	14 participants n=7 Participants	25 participants n=5 Participants
Region of Enrollment Russian Federation	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Body Mass Index (BMI)	33.2 kg/m² STANDARD_DEVIATION 5.30 • n=5 Participants	33.3 kg/m² STANDARD_DEVIATION 4.39 • n=7 Participants	33.3 kg/m² STANDARD_DEVIATION 4.80 • n=5 Participants
Daily Mean Plasma Glucose	170.2 mg/dL STANDARD_DEVIATION 27.86 • n=5 Participants	167.4 mg/dL STANDARD_DEVIATION 39.41 • n=7 Participants	169 mg/dL STANDARD_DEVIATION 34.33 • n=5 Participants
Duration of diabetes	12.1 years STANDARD_DEVIATION 7.29 • n=5 Participants	11.0 years STANDARD_DEVIATION 7.02 • n=7 Participants	11.5 years STANDARD_DEVIATION 7.13 • n=5 Participants
Glycosylated Haemoglobin (HbA1c)	7.8 percent STANDARD_DEVIATION 0.60 • n=5 Participants	8.0 percent STANDARD_DEVIATION 0.67 • n=7 Participants	7.9 percent STANDARD_DEVIATION 0.64 • n=5 Participants
Weight	91.5 kg STANDARD_DEVIATION 16.60 • n=5 Participants	92.9 kg STANDARD_DEVIATION 17.15 • n=7 Participants	92.3 kg STANDARD_DEVIATION 16.83 • n=5 Participants

PRIMARY outcome

Timeframe: at the end of treatment (week 24)

Population: Modified Intent to treat (ITT) population, LOCF (Last Observation Carried Forward)

Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c \<7%