|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
25 November 2019 |
|
Main ID: |
EUCTR2005-002614-38-GB |
|
Date of registration:
|
30/09/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
COMPARISON OF TWO THERAPEUTIC STRATEGIES FOR TREATING TYPE 2 DIABETIC PATIENTS POORLY CONTROLLED WITH BASAL INSULIN ASSOCIATED WITH ORAL ANTIDIABETIC DRUGS: 6-MONTH PROOF OF CONCEPT STUDY - BASAL PLUS
|
|
Scientific title:
|
COMPARISON OF TWO THERAPEUTIC STRATEGIES FOR TREATING TYPE 2 DIABETIC PATIENTS POORLY CONTROLLED WITH BASAL INSULIN ASSOCIATED WITH ORAL ANTIDIABETIC DRUGS: 6-MONTH PROOF OF CONCEPT STUDY - BASAL PLUS |
|
Date of first enrolment:
|
07/09/2006 |
|
Target sample size:
|
196 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002614-38 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Type 2 diabetic men or women
2. Aged 18 to 75 years
3. 25 < Body Mass Index (BMI) < 40 kg/m2
4. 7,5% = HbA1c = 9%
5. Treated with a basal insulin, and at least 1g metformin daily, for more than 3 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Type 1 diabetes mellitus
2. Treatment with OADs ( Oral Antidiabetic Drugs) only
3. Treatment with thiazolidinediones, with exenatide or with pramlintide
4. Treatment with an insulin other than basal insulin
5. Active proliferative diabetic retinopathy
6. Pregnancy
7. Breast-feeding
8. Treatment with systemic corticosteroids in the 3 months prior to study entry
9. Previous treatment with insulin glulisine
10. Impaired hepatic function at study entry
11. Impaired renal function at study entry
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Type II diabetes mellitus
MedDRA version: 8.1
Level: LLT
Classification code 10045242
|
|
Intervention(s)
|
Trade Name: Apidra 100 U/ml, solution for injection in cartridge
Product Name: Apidra 100 U/ml, solution for injection in cartridge
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glulisine
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Lantus 100 U/ml, solution for injection in a cartridge
Product Name: Lantus 100 U/ml, solution for injection in a cartridge
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Amaryl 1 mg, tablet
Amaryl 2 mg, tablet
Amaryl 3 mg, tablet
Amaryl 4 mg, tablet
Product Name: Amaryl 1mg, tablet - Amaryl 2 mg , tablet - Amaryl 3mg, tablet - Amaryl 4 mg, tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: Glimepiride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1; 2; 3; 4-
Trade Name: Metformin Tablets 500 mg
Metformin Tablets 850 mg
Product Name: Metformin SANDOZ 500mg Metformin SANDOZ 850 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500; 850-
|
|
Primary Outcome(s)
|
Secondary Objective: •To compare between the 2 treatment arms: evolution of HbA1c, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight, incidence of adverse events.
•To describe the impact of 2 different titration algorithms for insulin glulisine on blood glucose control in the arm with glulisine.
|
|
Main Objective: The primary objective of the study is to evaluate the efficacy (measured by the percentage of patients achieving an Hemoglobin A1c (HbA1c) level at the end of treatment period < 7%) of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
|
|
Primary end point(s): The primary efficacy variable will be the percentage of patients with HbA1c level at the end of treatment period < 7%.
|
|
Secondary ID(s)
|
|
HMR1964A/4002
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|