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Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart

Self-control Trial to Evaluate the Remission Rate and Safety in Newly Diagnosed Type 2 Diabetes Patients After Short-term Intensive Insulin Aspart and Insulin NPH Treatment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00494988
Enrollment
33
Registered
2007-07-02
Start date
2004-12-31
Completion date
2006-04-30
Last updated
2016-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.

Interventions

DRUGinsulin aspart
DRUGinsulin NPH

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Type 2 diabetes newly diagnosed within 6-12 months * FBG: 11.1-17.0 mmol/L * Body mass index (BMI) larger than 25.0 kg/m2

Exclusion criteria

* Known or suspected allergy to trial product(s) or related products * Recurrent major hypoglycaemia as judged by the Investigator

Design outcomes

Primary

MeasureTime frame
Remission rateafter 24 weeks

Secondary

MeasureTime frame
blood glucose profiles
HbA1c

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026