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CompletedNCT01492153Updated Feb 28, 2017

NovoLet® Surveillance Study on Using Human Insulin System in Indonesia

An observational study in Diabetes, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,981
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,981 is above the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,401 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with type 1 or type 2 diabetes mellitus or other types of diabetes mellitus (gestational, drug induced or metabolic syndrome-related) who are prescribed NovoLet® human insulin in the course of their diabetes mellitus management can be enrolled in the study

Eligibility criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
  • Other types of diabetes mellitus (gestational, drug induced [thiazide] or metabolic syndrome-related)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,981 participants (actual)
Patient registry
No

Groups and cohorts

  • NovoLet® device

    Drug: biphasic human insulin · Drug: isophane human insulin · Drug: human soluble insulin

Interventions

  • Drugbiphasic human insulin

    Drug pages: Insulin, Regular, Human · Insulin, Isophane

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

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

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

06

What researchers measure

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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Jakarta, 12520, Indonesia
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01492153
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Dec 14, 2011
Start date
Feb 11, 2003
Primary completion
Sep 5, 2006
Completion
Sep 5, 2006
Last update
Feb 28, 2017

Study contacts

Global Clinical Registry (GCR, 1457)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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