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

NCT03030300 | Completed Phase 4 DMC

• 1 other identifier: qfsnfm-005
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

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.

Conditions

Type2 Diabetes

Keywords

type 2 diabetes; remission; short-term intensive insulin therapy

Outcome Measures

Primary Outcomes (2)

• prolonged-remission rate

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

  5 years

• 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.

  5 years

Study Arms (1)

Novolin 30R;Pioglitazone;Metformin

EXPERIMENTAL

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

Novolin 30R;Pioglitazone;Metformin DRUG

* 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.

Novolin 30R;Pioglitazone;Metformin

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (3)

Shandong Provincial Hospital

Jinan, Shandong, 250001, China

Location

Qianfoshan Hospital

Jinan, Shandong, 250012, China

Location

Qilu Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lin Liao, MD

  Qianfoshan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of endocrinology department at Qianfoshan Hospital

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2008
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

CN (3)