Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)

NCT00627471 | Terminated Phase 4 DMC

• 1 other identifier: LANTU_L_02936
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice. To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice. To compare the percentage of patients achieving HbA1c\< 7% in each treatment group. To compare hypoglycaemic events (minor, severe and nocturnal) between groups. To compare average insulin dose between groups. To compare PRO (patients' reported outcomes) between groups. To compare mean changes in body weight between treatment groups.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean difference in HbA1c (efficacy)

  6 months

Secondary Outcomes (1)

• Minor, severe and nocturnal Hypoglycaemic events (safety)

  from the begining of the treatment up to 5 days after the end of the study

Study Arms (2)

A

ACTIVE COMPARATOR

This group must follow a defined algorithm. Only the physicians assigned to this group will know the algorithm.

Drug: Insulin Glargine

B

ACTIVE COMPARATOR

This is the control group, following the physician's standard practice.

Drug: Insulin Glargine

Interventions

Insulin Glargine DRUG

For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.

B

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes.
• Patients in treatment with OADs (one or more) for at least 1 year who failed metabolic control (HbA1c \> 8% and \< 11%).
• FBG \> 130 mg/dl and \< 240 mg/dl.
• BMI \< 40 kg/m2 and \>25 kg/m2.
• Ability and willingness to follow a tight anti-diabetic therapy and to perform SMBG controls.

You may not qualify if:

• C peptide \< 0.30 nmol/l.
• Unexplained weight loss of more than 10% of body weight in the last 6 months.
• Pregnant women or women with the intention of becoming pregnant.
• Women with childbearing potential who will not use contraceptive protection.
• Breastfeeding women.
• Patients using or that have used rapid or ultra-rapid acting insulins; except for those patients that have used rapid or ultra-rapid insulins during intercurrences such as AMI, severe infection or surgery.
• Renal impairment defined as serum creatinine \>1.4 mg/dl in women and \>1.5 mg/dl in men.
• Hepatic impairment defined as GPT or GOT above 2x the normal threshold.
• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (non selective beta blockers and systemic corticosteroids).
• History of drug or alcoholic abuse.
• Diabetic retinopathy with surgical treatment in the 3 months prior to study entry or which may require surgical treatment within 6 months of study entry.
• Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological, oncologic or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, at the discretion of the investigator.
• Evidence of an uncooperative attitude, including poor compliance to any anti- diabetic treatment.
• Known hypersensitivity to insulin glargine.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-aventis administrative office Argentina

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Cristian von Schulz-Hausmann

  Sanofi-aventis administrative office Argentina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 3, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Last Updated: June 2, 2010

Record last verified: 2010-06

Locations

AR (1)