Insulin Glargine in Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Pilot Study on Glycaemic Variability in Type 2 Diabetes Mellitus Patients With Basal Insulin and Fixed Combo Oral Antidiabetic Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272077
• Other study ID #: HOE901_3509
• Secondary ID: EudraCT # : 2004
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2006
• Last updated: December 4, 2009
• Start date: April 2005

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Primary objective:

To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).

Secondary objectives:

The secondary objectives are the assessment of: changes in glycaemic control (HbA1C), frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial weight, duration of diabetes mellitus, general education and diabetes education.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes mellitus for at least 5 years;

• Treatment with oral antidiabetic drugs in fixed combination (Combo, i.e. glibenclamide 2.5 mg + metformin 400 mg, 2 or 3 tablets, at stable dose in the last 3 months);

• HbA1c >= 8% and <= 11%;

• Body mass index (BMI) > 27 and < 35 kg/m2;

• Willingness and demonstrated ability to inject insulin;

• Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG);

Exclusion criteria:

• Patients diagnosed with type 1 insulin dependent diabetes;

• Patients with latent autoimmune diabetes of adults (LADA), defined as fasting C-peptide levels < 1 ng/ml;

• Cardiac status NYHA III-IV;

• Impaired renal function as shown by (but not limited to) serum creatinine >= 1.5 mg/dl for males or >= 1.4 mg/dl for females;

• Planned pregnancy, pregnant or lactating females;

• Failure to use adequate contraception (women of current reproductive potential only);

• Any current malignancy, previous breast cancer, or malignant melanoma within the past 5 years;

• Diagnosis of dementia

• Hypersensitivity to insulin or any of their components or to metformin;

• Current or previous insulin therapy other than during hospitalisations;

• Inability or unwillingness to continue metformin at study dosages throughout the study;

• Treatment with intermittent doses of systemic steroids or large doses of inhaled steroids for the past one year (fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regime);

• Stroke, Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), or Angina Pectoris within the last 12 months;

• History of drug or alcohol abuse;

• Receipt of an experimental drug or use of an experimental device within the 30 days prior to study entry;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insuline glargine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMBG values		during the last 4 weeks before visit 3 (end of cycle 1) and visit 4	No
Secondary	glycaemic control (HbA1c, fasting blood glucose, insulin and C-peptide),		During the study conduct	No
Secondary	frequency of hypoglycaemias		During the study conduct	No
Secondary	body weight		During the study conduct	No
Secondary	final insulin dose		During the study conduct	No
Secondary	lipid profile (serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)		During the study conduct	No
Secondary	urinary albumin-to-creatinine ratio		During the study conduct	No
Secondary	standard meal test		during the study conduct	No
Secondary	results of CGMS		During the study conduct	No