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CompletedNCT03030300Updated Jan 25, 2017

Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy

A Phase 4 interventional study of Novolin 30R;Pioglitazone;Metformin in Type2 Diabetes, sponsored by Qianfoshan Hospital. Completed at 3 sites in China. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2017-01-25.

Sponsored by Qianfoshan Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
170
Allocation
Not applicable
Ages
18 Years to 78 Years
Sex
All
01

Study summary

To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to the remission rate.

02

Conditions studied

  • Type2 Diabetes

Keywords

  • type 2 diabetes
  • remission
  • short-term intensive insulin therapy
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 170 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 78 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed, insulin-naive type 2 diabetes outpatients
  • Diabetes duration less than 1 year

Exclusion criteria

Exclusion Criteria:

  • Various acute complications
  • Hepatic transaminase >2.5x normal reference value (glutamic-pyruvic transminase>100U/L, glutamic-oxalacetic transaminase > 100U/L)
  • Abnormal renal functions (serum cretinine>the normal reference value)
  • Cardiac insufficiency (America NYHA caediac function >3)
  • Type 1 diabetes mellitus
  • Ongoing hormone therapy
  • Women in gestation and lactation
  • Patients with other endocrine disorders
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • Experimental
    Novolin 30R;Pioglitazone;Metformin

    Drugs: Insulin (Novolin 30R) monotherapy or combined with one or two oral drugs (metformin 0.5 mg tid and pioglitazone hydrochloride 15 mg qd).

    Drug: Novolin 30R;Pioglitazone;Metformin

Interventions

  • DrugNovolin 30R;Pioglitazone;Metformin

    * Insulin (Novolin 30R) was titrated according to the level of blood glucose until reached euglycemia (FPG≤6.1mmol/L and/or P2hBG≤8.0mmol/L and/or HbA1c ≤6.5%). After glucose was well controlled within these targets for 4 weeks, insulin dosage was gradually decreased until discontinued; * Pioglitazone hydrochloride was discontinued if the glucose was well controlled at the 6th week after the cessation of insulin; * Metformin was the last drug that to be discontinued if the glucose was still well controlled at the 4th week after the cessation of pioglitazone.

06

What researchers measure

Primary outcomes

  1. prolonged-remission rate

    hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.

    Time frame: 5 years

  2. partial-remission rate

    hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years.

    Time frame: 5 years

07

Study locations

3 sites
  • Shandong Provincial Hospital
    Jinan, Shandong 250001, China
  • Qianfoshan Hospital
    Jinan, Shandong 250012, China
  • Qilu Hospital
    Jinan, Shandong 250014, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

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

Registry details

Key details

Study ID
NCT03030300
Lead sponsor
Qianfoshan Hospital
Responsible party
Lin Liao (chief of endocrinology department at Qianfoshan Hospital, Qianfoshan Hospital) — Principal investigator
First posted
Jan 25, 2017
Start date
Jan 2008
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Jan 25, 2017

Study contacts

Lin Liao, MD
study chair · Qianfoshan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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