Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus

NCT05161741 | Completed Phase 4

• 1 other identifier: GTZ-DM-004-21
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study. Sample size: The estimated target sample size is n=230. Study duration: 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy.

• Primary (SAFETY Outcomes):
• Frequency of adverse events during the course of study follow-up.
• Frequency of serious adverse events.
• SECONDARY OUTCOME MEASURES (EFFICACY ENDPOINTS)
• Change from baseline in HbA1c% to the last-observation.
• Change from baseline in fasting plasma glucose to the last- observation on treatment Ethical consideration: The ethical approval of study is taken from an independent ethics committee. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.

Conditions

Adverse Drug Event; Effect of Drug; Type 2 Diabetes Treated With Insulin

Keywords

Insulin; Type 2 Diabetes mellitus; Safety; Efficacy

Outcome Measures

Primary Outcomes (3)

• Frequency of adverse events, serious adverse events during the course of study follow-up

  Drug safety

  6 months

• Change from baseline in HbA1c% to the last-observation

  Drug efficacy

  6 months

• Change from baseline in fasting plasma glucose to the last- observation on treatment

  Drug efficacy

  6 months

Study Arms (1)

Uncontrolled diabetes requiring Insulin

EXPERIMENTAL

Drug: Insulin

Interventions

Insulin DRUG

Human rDNA Insulin (Insuget, local brand of Getz Pharma)

Uncontrolled diabetes requiring Insulin

Eligibility Criteria

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

You may qualify if:

• Patients who give written informed consent.
• Type 2 diabetic males \& females with age 18 \& above years.
• HbA1c: 7.0% and above.
• Patients with uncontrolled Diabetes after intervention of lifestyle modifications plus oral and/or insulin therapy.

You may not qualify if:

• Known type 1 diabetes mellitus patients.
• History of severe hypoglycemia (\<70mg/dL)
• History of hypersensitivity to any of the active or inactive ingredients of the insulin preparations used in the trial, and/or history of significant allergic drug reactions.
• Presence of severe diabetes complications.
• History of renal and/or hepatic dysfunctions.
• Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
• History of acute coronary syndrome or stroke.
• Pregnant or lactating females.
• History of Acute psychiatric disorder or exacerbation of chronic psychiatric disorder.
• History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study

Sponsors & Collaborators

• Getz Pharma: lead

Study Sites (1)

Social Security Hospital

Lahore, Punjab Province, 54500, Pakistan

Location

Related Publications (4)

• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2008 Jan;31 Suppl 1:S55-60. doi: 10.2337/dc08-S055. No abstract available.

  PMID: 18165338 BACKGROUND

• Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.

  PMID: 9742976 BACKGROUND

• Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999 Jun 2;281(21):2005-12. doi: 10.1001/jama.281.21.2005.

  PMID: 10359389 BACKGROUND

• Wright A, Burden AC, Paisey RB, Cull CA, Holman RR; U.K. Prospective Diabetes Study Group. Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57). Diabetes Care. 2002 Feb;25(2):330-6. doi: 10.2337/diacare.25.2.330.

  PMID: 11815505 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: December 17, 2021
• Study Start: January 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 6, 2023

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)