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The efficacy and safety of Type 2 Diabetes Mellitus switch from three times-daily pre-mixed insulin or basal–bolus insulin to twice-daily Insulin degludec/aspart

The efficacy and safety of Type 2 Diabetes Mellitus switch from three times-daily pre-mixed insulin or basal–bolus insulin to twice-daily Insulin degludec/aspart

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037600
Enrollment
Unknown
Registered
2020-08-29
Start date
2020-08-31
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 disease

Interventions

Case series:Insulin degludec/aspart

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with type 2 diabetes >= 18 years old; (2) Diagnosis of type 2 diabetes over 6 months; (3) Premix insulin 3 times a day or basal meal insulin with or without oral hypoglycemic agents (OADs) for at least 12 weeks; (4) BMI <= 35kg/m2.

Exclusion criteria

Exclusion criteria: (1) Insulin allergy; (2) Total daily dose of insulin > 100U/d; (3) Use of drugs that may interfere with glucose metabolism before the experiment; (4) Women who are pregnant, breastfeeding or planning to pregnancy; (5) Acute and chronic infection and tumor; (6) History of cardiovascular and cerebrovascular diseases within 3 months, including stroke, decompensated heart failure (NYHA III or IV), myocardial infarction, coronary artery bypass grafting or angioplasty; (7) Untreated or uncontrolled severe hypertension, in which severe hypertension refers to SBP>=180mmHg and/or DBP>=100mmHg; (8) Severe liver or kidney function damage; (9) Recurrent episodes of severe hypoglycemia or hypoglycemia coma or hospitalization due to diabetic ketoacidosis within 3 months.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
FBG;SMPG;Total daily dose of insulin needed;DTSQ;the incidence of hypoglycemia;

Countries

China

Contacts

Public ContactHuabing Zhang

Department of Endocrinology, Key Laboratory of Endocrinology, National Health Commission, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

huabingzhang@sina.com+86 13671312474

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026