Insulin Glulisine in Type 2 Diabetic Patients - Study Results

Insulin Glulisine in Type 2 Diabetic Patients (Basal Plus)

This study has been completed.

Study NCT00360698 Information provided by Sanofi-Aventis

First Received on August 3, 2006. Last Updated on August 1, 2011 History of Changes

Results First Received: August 20, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Insulin Glargine Drug: Glimepiride Drug: Insulin Glulisine Drug: Metformin

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During Run-In period patients were not assigned to a treatment group. They were all treated with Insulin Glargine + Metformin + Glimepiride.

Reporting Groups

	Description
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)

Participant Flow for 2 periods

Period 1: Run-In

	Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride	Insulin Glargine+Metformin+Glimepiride
STARTED	0	135
COMPLETED	0	125 ^[1]
NOT COMPLETED	0	10
Physician Decision	0	1
Withdrawal by Subject	0	2
Non compliance with treatment procedure	0	1
Sponsor request	0	2
Patient did not meet inclusion criteria	0	1
Patient personal reasons	0	2
Need of insulin with meals	0	1

[1]	19 patients completed the run-in but were not eligible for randomization in the treatment period

Period 2: Treatment Period

	Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride	Insulin Glargine+Metformin+Glimepiride
STARTED	49	57
COMPLETED	48	56
NOT COMPLETED	1	1
Non compliance with treatment procedure	1	0
Early termination by error	0	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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)

Baseline Measures

	Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride	Insulin Glargine+Metformin+Glimepiride	Total
Number of Participants [units: participants]	49	57	106
Age [units: years] Mean ± Standard Deviation	60.6 ± 6.73	59.3 ± 8.84	59.9 ± 7.92
Gender [units: participants]
Female	29	35	64
Male	20	22	42
Region of Enrollment [units: participants]
United States	23	27	50
United Kingdom	11	14	25
Russian Federation	15	16	31
Body Mass Index (BMI) ^[1] [units: kg/m²] Mean ± Standard Deviation	33.2 ± 5.30	33.3 ± 4.39	33.3 ± 4.80
Daily Mean Plasma Glucose ^[2] [units: mg/dL] Mean ± Standard Deviation	170.2 ± 27.86	167.4 ± 39.41	169 ± 34.33
Duration of diabetes [units: years] Mean ± Standard Deviation	12.1 ± 7.29	11.0 ± 7.02	11.5 ± 7.13
Glycosylated Haemoglobin (HbA1c) [units: percent] Mean ± Standard Deviation	7.8 ± 0.60	8.0 ± 0.67	7.9 ± 0.64
Weight ^[1] [units: kg] Mean ± Standard Deviation	91.5 ± 16.60	92.9 ± 17.15	92.3 ± 16.83

[1]	Total patients analyzed n=105 due to one missing data in the "insulin glulisine+insulin glargine+metformin+glimepiride" group
[2]	Patients having a baseline value and a value on treatment: insulin glulisine+insulin glargine+metformin+glimepiride group n=47 patients, insulin glargine+metformin+glimepiride group n=55 patients

[1]

Total patients analyzed n=105 due to one missing data in the "insulin glulisine+insulin glargine+metformin+glimepiride" group

[2]

Patients having a baseline value and a value on treatment:

insulin glulisine+insulin glargine+metformin+glimepiride group n=47 patients, insulin glargine+metformin+glimepiride group n=55 patients

Outcome Measures

Show All Outcome Measures

1. Primary:

Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% [ Time Frame: at the end of treatment (week 24) ]

Show Outcome Measure 1

2. Secondary:

Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: at the end of treatment (week 24) ]

Show Outcome Measure 2

3. Secondary:

Change in Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: from baseline to the end of treatment (week 24) ]

Show Outcome Measure 3

4. Secondary:

Daily Mean Plasma Glucose [ Time Frame: at the end of treatment (week 24) ]

Show Outcome Measure 4

5. Secondary:

Change in Daily Mean Plasma Glucose [ Time Frame: from baseline to the end of treatment (week 24) ]

Show Outcome Measure 5

6. Secondary:

Change in Weight [ Time Frame: from baseline to the end of treatment (week 24) ]

Show Outcome Measure 6

7. Secondary:

Daily Dose of Insulin Glargine [ Time Frame: at the end of treatment (week 24) ]

Show Outcome Measure 7

8. Secondary:

Daily Dose of Insulin Glulisine [ Time Frame: at the end of treatment (week 24) ]

Show Outcome Measure 8

9. Secondary:

Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL [ Time Frame: during treatment period (12 weeks) ]

Show Outcome Measure 9

10. Secondary:

Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL [ Time Frame: during treatment period (12 weeks) ]

Show Outcome Measure 10

11. Secondary:

Rate of Severe Symptomatic Hypoglycemia [ Time Frame: during treatment period (12 weeks) ]

Show Outcome Measure 11

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Affairs study director
Organization: sanofi-aventis
e-mail: publicregistryGMA@sanofi-aventis.com

No publications provided

Responsible Party:	Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00360698 History of Changes
Other Study ID Numbers:	HMR1964A_4002, EUDRACT # : 2005-002614-38
Study First Received:	August 3, 2006
Results First Received:	August 20, 2009
Last Updated:	August 1, 2011
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration