Superiority of insulin glargine Lantus vs. NPH: “Treat to Normoglycemia concept”. Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled. - LANCELOT

• Register: EUCTR
• Last refreshed on: 16 September 2013
• Main ID: EUCTR2007-006640-22-CZ
• Date of registration: 29/07/2008
• Prospective Registration: Yes
• Primary sponsor: SANOFI-AVENTIS GROUPE
• Public title: Superiority of insulin glargine Lantus vs. NPH: “Treat to Normoglycemia concept”. Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled. - LANCELOT
• Scientific title: Superiority of insulin glargine Lantus vs. NPH: “Treat to Normoglycemia concept”. Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled. - LANCELOT
• Date of first enrolment: 18/11/2008
• Target sample size: 670
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006640-22
• 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

Countries of recruitment

Czech Republic, France, Italy, Netherlands, Poland, Spain, Sweden

Contacts

• Affiliation: SANOFI-AVENTIS GROUPE

• Affiliation: SANOFI-AVENTIS GROUPE

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria
• Aged from 30 to 70 years inclusively
• Insulin-naïve type 2 diabetes mellitus
• Type 2 diabetes mellitus diagnosed for at least 1 year
• Treated with at least one OAD (Metformin [daily dose of at least 1000mg], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
• HbA1c > or = 7.0% and < or = 10.5%
• BMI < 40 kg/m2
• Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
• Informed consent obtained in writing at enrolment into the study
• Willingness and ability to comply with the study protocol

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:
Exclusion criteria:
• Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
• Treatment with TZD as monotherapy
• Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake
• Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
• Impaired renal function: serum creatinine = 1.5 mg/dL (= 133µmol/L) or = 1.4 mg/dL (= 124 µmol/L) in men and women, respectively
• History of sensitivity to the study drugs or to drugs with a similar chemical structure
• Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range)
• Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
• Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
• Treatment with an investigational product in the 30 days prior to visit 1
• Alcohol or drug abuse in the last year
• Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient’s safety or limit the patient successful participation in the study (including night shift worker)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus
MedDRA version: 13.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Trade Name: Lantus
Product Name: insulin glargine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin glargine
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Insuman Basal
Product Name: insulin human
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: insulin human
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: Primary:
To demonstrate the superiority of insulin glargine over insulin NPH on the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective: Main Secondary:
To compare between treatment groups:
• Plasma glucose (fasting, nocturnal) over time,
• Changes from baseline in HbA1c over time,
• Percentage of patients who reach the target of HbA1c <7% and <6.5%,
• Use of prandial insulin as rescue medication at month 6
• Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
• Daily dose of insulin,
• Change in body weight from baseline,
• Evolution of 8-point plasma-glucose (PG) profiles,
• Overall safety,
• Patient reported outcomes (treatment satisfaction).

Primary end point(s): Change in HbA1c from baseline to end of study treatment in ITT population
Data collected for the assessment of efficacy and safety criteria:
At specific time points:
• HbA1c recorded at baseline, weeks 12, 24 and 36
• Self-monitored fasting plasma glucose assessment over 6 consecutive days before baseline, weeks 12, 24 and 36
• During the week before baseline, at 12, 24 and 36 weeks, patients will do a 8-point plasma glucose profile twice a week (at their convenience): immediately before and 2 hours after breakfast, lunch and dinner, at bedtime and at 3:00 a.m before insulin initiation and 5 to 6 hours after insulin injection during the treatment period. One or both of these nocturnal values will be used for insulin titration.
• Need of additional a prandial insulin at month 6
• Body weight measured at baseline, weeks 4, 8, 12, 24 and 36
• Daily doses of insulin at each visit,
• Lipid profile at baseline and week 36 ,
• Patient reported outcomes: Treatment satisfaction will be assessed using the DTSQs at baseline, weeks 12, 24 and 36 and the DTSQc at week 36.
• Vital signs at each visit,

All across the study:
• Episodes of hypoglycemia.
• Adverse events

Secondary ID(s)

2007-006640-22-ES

LANTU_C_02762

Source(s) of Monetary Support

SANOFI-AVENTIS GROUPE