Nippon Ultra-Rapid Insulin and Diabetic Complication Evaluation-Study (NICE-Study)

NCT00575172 | Completed DMC

• 2 other identifiers: UMIN0949UMIN00000949
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

For the purpose of comparing efficacy of intensive therapy between 1) ultrarapid-acting type insulin (insulin aspart) and 2) conventional rapid-acting type insulin (R), a Multicenter Open Label Randomized Controlled Trial was planned in Japan using the occurrence of cardiovascular events in patients with diabetes, a high risk factor, as an index.

Conditions

Diabetes Mellitus

Keywords

type2 diabetes mellitus; cardiovascular disease; macrovascular event

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events 1)Sudden death 2)New development or recurrence of apoplexy or TIA 3)New development or recurrence of AMI or and angina pectoris 4)Newly developed ASO, amputation of leg due to ASO

  five years

Secondary Outcomes (1)

• 1)Total mortality 2)Changes in the mean IMT of common carotid arteries 3)Changes in the pulse wave velocity (PWV) (rt & 1t baPWV), ABI

  five years

Study Arms (2)

U

Intensified insulin therapy with ultrarapid insulin-analogue (Insulin-Aspart)

R

Intensified insulin therapy with human regular insulin

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Japanese outpatients and inpatients aged 20 years or more but younger than 85 years. Men or women. Patients with type 2 diabetes based on the diagnostic standard of the Japanese Diabetes Society/American Diabetes Association. No specific restriction on the current treatment. Patients having switched treatment are also accepted.

You may qualify if:

• Subjects are patients satisfying the following conditions 1) - 3).
• Outpatients and inpatients aged 20 years or more but younger than 85 years. Men or women.
• Patients with type 2 diabetes based on the diagnostic standard of the Japanese Diabetes Society
• No specific restriction on the current treatment. Patients having switched treatment are also accepted.

You may not qualify if:

• Patients with type 1 diabetes
• Patients with a past history of cerebral angiopathy (cerebral hemorrhage, cerebral infarction, transient cerebral ischemic attack, subarachnoid hemorrhage, etc.) within 6 months before giving consent
• Patients with a past history of myocardial infarction within 6 months before giving consent
• Patients planning to receive PTCA or CABG, or who had PTCA or CABG within 6 months before giving consent
• Patients with coronary arteriopathy (angina pectoris, etc.) that requires treatment with β-blocker or calcium-antagonist
• Patients with atrial fibrillation or atrial flutter
• Patients with renal dysfunction (serum creatinine ≥ 3.0 mg/dL)
• Patients with liver dysfunction (AST, ALT ≥ 100 IU/L)
• Patients with a past history or suspected of having a malignant tumor within 5 years before giving consent
• Pregnant or possibly pregnant patients
• Other patients judged inappropriate for the study by the investigators (patients presenting difficulty in frequently receiving rapid-acting type insulin or ultrarapid-acting type insulin therapy, including patients' compliance with treatment)

Sponsors & Collaborators

• Osaka Saiseikai Nakatsu Hospital: lead

Study Sites (1)

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, 503-0012, Japan

Location

Related Publications (1)

• Nishimura H, Shintani M, Kouji M and Nice-study group J Saiseikai Nakatsu Hospital, 20, 216-220, 2003

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Hideshi Kuzuya, M.D.,Ph.D

  Higasiyama Takeda Hospital

  STUDY CHAIR

• Makoto Otoshi, MD.,Ph.D.

  Ohtoshi Clinic

  STUDY DIRECTOR

• Haruo Nishimura, MD.,Ph.D.

  Osaka Saiseikai Nakatsu Hospital

  PRINCIPAL INVESTIGATOR

• Koji Maeda, MD.

  Maeda Clinic

  PRINCIPAL INVESTIGATOR

• Mitsuyo Shintani, MD.,Ph.D.

  Osaka Saiseikai Nakatsu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 18, 2007
• Study Start: March 1, 2003
• Study Completion: December 1, 2007
• Last Updated: January 14, 2008

Record last verified: 2007-12

Locations

JP (1)