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TerminatedNCT00799448Updated Feb 20, 2017

Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes

A Phase 4 interventional study of repaglinide and biphasic human insulin 30 in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Terminated at 1 site in Greece. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-20.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Why this study was terminated
Low recruitment status

From the registry’s dates

  • Registered 5 years 2 months after the study started (first participant enrolled Sep 2003, registered Nov 2008).
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 8,367 interventional 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
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • HbA1c: 7.5-11.0% on current therapy
  • OHA (oral hypoglycaemic agent) treatment for a minimum of two years
  • BMI (body mass index): 25-32 kg/m2
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Interventions

  • Drugrepaglinide
  • Drugbiphasic human insulin 30
  • Druginsulin NPH
06

What researchers measure

Primary outcomes

  1. HbA1c

    Time frame: after 20 weeks of treatment

Secondary outcomes

  1. Fasting blood glucose (FBG)

  2. Incidence of hypoglycaemic episodes

  3. Adverse events

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Athens, 15127, Greece
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00799448
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Nov 27, 2008
Start date
Sep 16, 2003
Primary completion
Sep 20, 2004
Completion
Sep 20, 2004
Last update
Feb 20, 2017

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 terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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