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Completed

NCT Number: NCT01492153

NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
  • Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)

Treatment and study plan

biphasic human insulin

Drug

NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator

isophane human insulin

Drug

NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator

human soluble insulin

Drug

NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator

Primary outcomes

  1. Change in body weight

Secondary outcomes

  1. Fasting blood glucose (FBG)

  2. 2 hours postprandial blood glucose (2-hr PPBG)

  3. HbA1c (glycosylated haemoglobin)

  4. Adverse events (AEs) including hypoglycaemic episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Post Marketing Surveillance on the Use of NovoLet® Human Insulin System in Indonesia

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Dec 14, 2011
Registry last updated
Feb 28, 2017

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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