A 24-week, multicenter, international, randomized (1:1), parallel-group, open-label, comparative study of insulin glargine versus liraglutide in insulin-naïve patients with Type 2 diabetes treated with oral agents and not adequately controlled, followed by a 24-week extension period with insulin glargine for patients not adequately controlled with liraglutide

Phase 4

Completed

Conditions: Diabetic
Type 2 diabetes
10018424

Registration Number: NL-OMON36367

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Inclusion criteria for the comparative period:;- Patients aged from 35 to 75 years inclusively,
- With Type 2 Diabetes diagnosed for at least 1 year,
- Treated with lifestyle interventions and metformin at the maximum tolerated dosage (with a minimum daily dosage of 1g), either alone or in combination with an oral insulin secretagogue (sulfonylurea, glinide or DPP-IV inhibitor), for more than 3 months,
- 7.5% < HbA1c <= 12%,
- BMI between 25 and 40 kg/m2 inclusively ,
- Ability and willingness to perform PG self monitoring using the sponsor-provided glucose meter and to complete the patient diary,
- Willingness and ability to comply with the study protocol,
- Signed informed consent obtained prior to any study procedure.;Inclusion criteria for the extension period:;- Patients treated with liraglutide (at the maximum tolerated dosage), having a mean FPG >= 250 mg/dL at Visit 10 or Visit 11, or a HbA1c >= 7% at Visit 12
- Dosage of metformin compliant with the inclusion criterion of Visit 1 (i.e. maximum tolerated dosage, with a minimum daily dosage of 1g), and maintained stable during the comparative period.

Exclusion Criteria

Exclusion criteria for the comparative period:;- Previous treatment with GLP-1 analogues or insulin (for in the past year (except in case of temporary treatment for gestational diabetes, surgery,
hospitalization*),
- Treatment with thiazolidinediones or a-Glucosidases inhibitors within 3 months prior to study entry,
- Diabetes other than Type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake*),
- Pregnant women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method),
- Lactating women,
- Hospitalized patients (except hospitalization for routine diabetes check-up),
- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by a retina examination within 2 years prior to study entry,
- Impaired renal function (creatinine clearance < 60 mL/mn),
- Impaired hepatic function (ALT, AST >= 2.5 times the upper limit of normal range),
- Personal or family history of medullary thyroid carcinoma,
- Multiple endocrine neoplasia syndrome type 2,
- Severe gastro-intestinal disease (including inflammatory bowel disease or diabetic gastroparesis),
- Congestive heart failure,
- History of acute pancreatitis,
- Treatment with corticosteroids with potential systemic action for more than 10 days within 3 months prior to study entry,
- Alcohol or drug abuse in the past 5 years,
- History of sensitivity to the study drugs or to drugs with a similar chemical structure.
- Night shift worker,
- Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patient*s safety or limit the patient successful participation in the study.;Exclusion criteria for the extension period:;- Treatment with oral antidiabetic drugs other than metformin and patient*s usual sulfonylurea if any, or with insulin during the comparative period (except in case of an emergency, for a period of time less than 7 days),
- Treatment with corticosteroids with potential systemic action within the last 3 months of the comparative period,
- Pregnant women (women of childbearing potential must have a negative pregnancy test at extension period entry and a medically approved contraception method),
- Lactating women,
- Hospitalized patients (except hospitalization for routine diabetes check-up),
- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence during the comparative period, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the extension period,
- Impaired renal function (creatinine clearance < 60 mL/mn),
- Impaired hepatic function (ALT, AST >= 2.5 times the upper limit of normal range),
- History of sensitivity to insulin glargine.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main criterion will be the percentage of patients reaching a HbA1c < 7% at<br /><br>the end of the comparative period<br /><br>(week 24).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the effect of insulin glargine in comparison with liraglutide on:<br /><br>* HbA1c level<br /><br>* Percentage of patients whose HbA1c has decreased but remains >= 7% at the end<br /><br>of the comparative period<br /><br>* Percentage of patients whose HbA1c has increased at the end of the<br /><br>comparative period<br /><br>* Fasting Plasma Glucose (FPG)<br /><br>* 7-point Plasma Glucose (PG) profiles<br /><br>* Hypoglycemia occurrence<br /><br>* Body weight<br /><br>* Adverse events<br /><br>* Patient reported outcome measures (PROMs): DTSQs, DTSQc and ADDQoL<br /><br>* Diabetes specific treatment costs</p><br>