COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03030300
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
Lin Liao, Qianfoshan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: Novolin 30R;Pioglitazone;Metformin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
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
  • 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.

Primary Outcome Measures :
  1. prolonged-remission rate [ Time Frame: 5 years ]
    hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.

  2. partial-remission rate [ Time Frame: 5 years ]
    hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03030300

Layout table for location information
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250001
Qianfoshan Hospital
Jinan, Shandong, China, 250012
Qilu Hospital
Jinan, Shandong, China, 250014
Sponsors and Collaborators
Qianfoshan Hospital
Layout table for investigator information
Study Chair: Lin Liao, MD Qianfoshan Hospital
Layout table for additonal information
Responsible Party: Lin Liao, chief of endocrinology department at Qianfoshan Hospital, Qianfoshan Hospital Identifier: NCT03030300    
Other Study ID Numbers: qfsnfm-005
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lin Liao, Qianfoshan Hospital:
type 2 diabetes
short-term intensive insulin therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs