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CompletedNCT00709475LevSafeQDUpdated Oct 28, 2016

Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus

An observational study in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Saudi Arabia. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by Novo Nordisk A/S · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
747
Ages
6 Years and older
Sex
All
01

Study summary

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 747 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

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

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Type 2 diabetic patients

Inclusion criteria

  • After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion criteria

Exclusion Criteria:

  • Subjects who are unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for the final visit;
  • Subjects currently being treated with insulin detemir;
  • Subjects who previously enrolled in this study or studies related to NovoMix 30;
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
747 participants (actual)
Patient registry
No

Groups and cohorts

  • A

    Drug: insulin detemir

Interventions

  • Druginsulin detemir

    Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

    Also known as: Levemir®, NN304

06

What researchers measure

Primary outcomes

  1. Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events

    Time frame: For the duration of the study (32 weeks)

Secondary outcomes

  1. Number of serious adverse events

    Time frame: For the duration of the study

  2. Number of all adverse events

    Time frame: For the duration of the study

  3. Number of all - daytime and nocturnal - hypoglycaemic events

    Time frame: In the 4 weeks before baseline compared to 4 weeks before interim and final visits

  4. Weight changes compared to baseline

    Time frame: At the end of the study

  5. HbA1c compared to baseline

    Time frame: At the end of the study

  6. Fasting glucose level control compared to baseline as measured by FBG

    Time frame: After 16 and 32 weeks of treatment

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Riyadh, 3542, Saudi Arabia
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00709475
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jul 3, 2008
Start date
May 2008
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Oct 28, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
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 Oct 2016. You cannot join it, but the record below documents what was studied.

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