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

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ClinicalTrials.gov Identifier: NCT03030300
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
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

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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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03030300


Locations
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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
Investigators
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Study Chair: Lin Liao, MD Qianfoshan Hospital
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Responsible Party: Lin Liao, chief of endocrinology department at Qianfoshan Hospital, Qianfoshan Hospital
ClinicalTrials.gov 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
remission
short-term intensive insulin therapy
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs