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OpenTrials
Completed

NCT Number: NCT01122979

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.

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 076-007, Curitiba, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

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

NPH insulin (insulin isophane)

Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

insulin glulisine

Drug

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

Regular insulin

Drug

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL.

    Time frame: From baseline and Visit 13 (Day 169)

  3. 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)

  4. Weight variation

    Time frame: From baseline to the end of treatment at visit 13 (day 169)

  5. Creatinine clearance variation

    Time frame: From baseline to the end of treatment at visit 13 (day 169)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Acronym: DINAMO

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 13, 2010
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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