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Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure. (DINAMO)

This study is currently recruiting participants.
Verified December 2012 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01122979
First received: May 11, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

Primary Objective:

>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.

Secondary Objectives:

  • Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment.
  • Incidence of confirmed symptomatic and nocturnal hypoglycemia.
  • Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment.
  • Creatinine clearance at baseline and after each period of treatment.
  • Overall safety: Incidence of adverse events.

Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: INSULIN GLARGINE
Drug: NPH insulin (insulin isophane)
Drug: INSULIN GLULISINE
Drug: Regular insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%. [ Time Frame: From visit 1 (Day 1) to visit 13 (Day 169) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL). [ Time Frame: From baseline and Visit 13 (Day 169) ] [ Designated as safety issue: No ]
  • Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL. [ Time Frame: From baseline and Visit 13 (Day 169) ] [ Designated as safety issue: No ]
  • Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration [ Time Frame: From baseline and Visit 13 (Day 169) ] [ Designated as safety issue: No ]
  • Weight variation [ Time Frame: From baseline to the end of treatment at visit 13 (day 169) ] [ Designated as safety issue: No ]
  • Creatinine clearance variation [ Time Frame: From baseline to the end of treatment at visit 13 (day 169) ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: July 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1: insulin glargine + insulin glulisine
insulin glargine once daily + glulisine at meal times
 Drug: INSULIN GLARGINE
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Drug: INSULIN GLULISINE
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Active Comparator: group 2 NPH insulin + regular insulin
NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times
 Drug: NPH insulin (insulin isophane)
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
Drug: Regular insulin
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c >= 8%.
  • Albuminuria or microalbuminuria diabetic retinopathy.
  • Creatinine clearance < 60 mL/min/1,73 m2 and >30 mL/min/1,73 m2

Exclusion criteria:

  • Hypersensibility to insulin glargine or any other component of the insulin formulation.
  • Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months.
  • History of diabetic ketoacidosis or positive GAD antibodies.
  • Advanced retinopathy needing laser therapy.
  • Diagnosed advanced neuropathy
  • Severe hepatic disease or active hepatitis.
  • Cardiac failure class III or IV (NYHA).
  • Patients on hemodialysis.
  • Diagnosed cancer.
  • Active infection.
  • Current therapy with steroids.
  • Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01122979

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

Locations
Brazil
Investigational Site Number 076-007 Recruiting
Curitiba, Brazil, 80060-900
Investigational Site Number 076-001 Recruiting
Fortaleza, Brazil, 60115-282
Investigational Site Number 076-010 Recruiting
Fortaleza, Brazil, 60015-052
Investigational Site Number 076-003 Recruiting
Porto Alegre, Brazil, 91350-250
Investigational Site Number 076-004 Recruiting
São Paulo, Brazil, 01323-001
Investigational Site Number 076-005 Recruiting
São Paulo, Brazil, 01244-030
Investigational Site Number 076-002 Recruiting
São Paulo, Brazil, 04024-002
Investigational Site Number 076-009 Recruiting
São Paulo, Brazil, o4039-000
Investigational Site Number 076-013 Recruiting
São Paulo, Brazil, 01308-050
Investigational Site Number 076-006 Recruiting
Taguatinga, Brazil, 72155000
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01122979     History of Changes
Other Study ID Numbers: LANTU_L_04737
Study First Received: May 11, 2010
Last Updated: December 19, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Insulin glulisine
Insulin
Insulin, NPH
Insulin, Long-Acting
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013