Loading clinical trials...

Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled

NCT00949442•Sanofi

View on ClinicalTrials.gov

Summary

Primary Objective: To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period. Secondary Objective: 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).

Eligibility

Age

30 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

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 \> or =1.5 mg/dL (\> or = 133µmol/L) or \> or = 1.4 mg/dL (\> or = 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
+3 more criteria

Locations (87)

Investigational Site Number 076-001

Fortaleza, Brazil

Investigational Site Number 076-006

Fortaleza, Brazil

Investigational Site Number 076-005

Porto Alegre, Brazil

Investigational Site Number 076-007

Rio de Janeiro, Brazil

Investigational Site Number 076-004

São Paulo, Brazil

Investigational Site Number 076-003

São Paulo, Brazil

Investigational Site Number 076-002

São Paulo, Brazil

Investigational Site Number 203003

Beroun, Czechia

Investigational Site Number 203001

Chrudim III, Czechia

Investigational Site Number 203008

České Budějovice, Czechia

Key Dates

Start Date

July 1, 2009

Primary Completion Date

July 1, 2012

Completion Date

July 1, 2012

Last Updated

August 21, 2012

Enrollment

708

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine (HOE901) [Lantus]

DRUG

Glimepiride

DRUG

human insulin [NPH]

DRUG

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

View study

RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)