CClinicalTrials.gg
Status unknownNCT01588743Updated May 1, 2012

Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients

An interventional study of insulin aspart in Type 2 Diabetes Mellitus, sponsored by Li Guangwei. Status unknown. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-05-01.

Sponsored by Li Guangwei · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
25 Years to 60 Years
Sex
All
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Study summary

It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.

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Conditions studied

  • Type 2 Diabetes Mellitus
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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 planned enrollment of 130 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Li Guangwei as lead sponsor.

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

04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age: 25 to 60 years old
  • Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication.
  • Fasting blood glucose is above 11.0mmol/L.
  • Half of the patients with BMI below 24 and the other half with BMI above 24.

Exclusion criteria

Exclusion Criteria:

  • type 1 diabetes mellitus
  • type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress)
  • Presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Interventions

  • Druginsulin aspart

    Insulin Aspart will be administrated by insulin pump with an initial dose of 0.4-0.6u/kg body weight, of which 50% basal rate and the other 50% bolus dose. Time interval for administration will be as follows: 0-3Am-9Am-12Am-5Pm-9Pm-0Am. Specific adjustment will be made according to individual difference.

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What researchers measure

Primary outcomes

  1. AUC75-120 of Glucose Infusion Rate (GIR)

    Time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments

Secondary outcomes

  1. AUC0-10 of Acute Insulin Response (AIR) during IVGTT

    Time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Wang H, Kuang J, Xu M, Gao Z, Li Q, Liu S, Zhang F, Yu Y, Liang Z, Zhao W, Yang G, Li L, Wang Y, Li G. Predictors of Long-Term Glycemic Remission After 2-Week Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2153-2162. doi: 10.1210/jc.2018-01468. PubMed 30629195 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01588743
Lead sponsor
Li Guangwei
Responsible party
Li Guangwei (Professor, China-Japan Friendship Hospital) — Sponsor-investigator
First posted
May 1, 2012
Start date
Oct 2008
Primary completion
Dec 2012 (estimated)
Last update
May 1, 2012

Study contacts

Guangwei Li
principal investigator · China-Japan Friendship Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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