Comparison of Premixed Insulin With Basal-plus Insulin in Type 2 Diabetes Patients

NCT02219750 | Completed Phase 4 DMC

• 1 other identifier: 13MMHISO71,13MMHISO72
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of efficacy and safety of different insulin regimens between basal bolus and premixed insulin in poorly controlled type 2 diabetes

Conditions

Diabetes

Keywords

premix insuiln, basal-plus insulin

Outcome Measures

Primary Outcomes (1)

• HbA1c

  To compare the change in HbA1c from baseline to endpoint for each groups at Week 24

  24week duration

Secondary Outcomes (5)

• achieving goal percentage

  24weeks duration

• plasma glucose

  24 week duration

• weight change

  24 weeks duration

• incidence of hypoglcyemia

  24 weeks duration

• total insulin dose

  24 weeks duration

Other Outcomes (1)

• C peptide

  24weeks

Study Arms (2)

Preprandial premix therapy

ACTIVE COMPARATOR

switch twice-daily insulin Preprandial premix therapy mean that transition of advance insulin based on the basal insulin daily total dose at study entry divided into two equal dose of preprandial NovoMix 30. Patient discontinued all pre-study oral antidiabetic drug(OAD), including sulfonylureas, glinides, Thiazolidinedione(TZD) and Dipeptidyl peptidase-4(DPP-4) inhibitor but left metformin alone

Drug: switch twice-daily insulin

Basal-plus insulin

ACTIVE COMPARATOR

switch twice-daily insulin Basal-plus insulin consisted of continued previous basal insulin and add-on once-daily insulin aspart(NovoRapid) before breakfast. The starting dose of insulin aspart was 4 unit(U) before breakfast and continued under previous basal insulin dose.

Drug: switch twice-daily insulin

Interventions

switch twice-daily insulin DRUG

compare two different insuiln regimen in basal insuln base and premixed insulin. NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin

Also known as: NovoMix® 30 Penfill®, lantus®, levemir®, NovoRapid®

Basal-plus insulin; Preprandial premix therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with type 2 diabetes.(World Health Organization classification) \> 20 years of age.
• Patients who have received stable doses of any OADs for at least 12 weeks prior to the screening visit.
• treatment with basal insulin plus OADs \>3 months with suboptimal glycemic control (HbA1c \>7%)
• FBG \<130 mg/dl or FBG ≥130 mg/dl, but daily insulin dose \>0.7U/kg or had history of nocturnal hypoglycemia
• Patients who are willing and able to cooperate with study and give signed informed consent.

You may not qualify if:

• Patients with type 1 diabetes.
• History of severe hypoglycemia or hypoglycemia unawareness within prior 6 months.
• Patients who had received any investigational insulin for more than 3 months or who have received investigational insulin treatment within 4 weeks prior to screening visit.
• Patients hypersensitive with insulin analog or its excipients.
• Patients who are currently pregnant/lactating, or who are preparing for pregnancy or lactation.
• Renal dialysis patients, patients with severe liver disease or congestive heart failure
• BMI \>40kg/m2
• Excessive insulin resistance (total daily insulin dose\>2.0unit/kg)

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memerial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine; Insulin Detemir; Insulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Sung-Chen Liu, master

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mackay Memorial Hospital

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 19, 2014
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 17, 2018

Record last verified: 2016-03

Locations

TW (1)