Description
This guidance is intended to help sponsors develop antidiabetic drugs for adults and children with type 1 diabetes mellitus (T1D) and/or type 2 diabetes mellitus (T2D). In this guidance, antidiabetic drugs refer to drugs intended to improve glycemic control, including drugs intended to reduce diabetes-related hyperglycemia (i.e., antihyperglycemic drugs) and drugs intended to mitigate iatrogenic hypoglycemia associated with diabetes management.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2intended to improve glycemic control; Clinical trials investigating antidiabetic drugs and biological products; drugs investigated for glycemic control
Requires analytical comparability per ICH Q5E
Stakeholders
2Assist sponsors in the nonclinical evaluation
responsible for justifying omission of studies
Regulatory Context
Regulatory Activities
1A1C is adequate to support traditional drug approval
Document Types
1official product information including clinical studies section
Attributes
3device performance metric for CGM
Commonly used margin of 0.3 percent for A1C
Sensor performance characteristic
Technical Details
Substances
3A manufacturer of insulin develops a mobile app intended for use with their insulin product.
Antihyperglycemic drug that can cause iatrogenic hypoglycemia
injected insulin for patients with T1D
Testing Methods
4additional efficacy endpoint
additional efficacy endpoint
Assessment of the proportion of subjects who achieve improvements in A1C
short-term studies to demonstrate pharmacodynamic activity
Clinical Concepts
10autoimmune-mediated pancreatic beta cell destruction
major comorbidities associated with excess adiposity; Common weight-related comorbidity
patients with type 2 diabetes may face unique safety issues such as a risk for hypoglycemia
chronic hyperglycemia as a result of defective insulin secretion
life-threatening acute event primarily in T1D; diabetes-related safety issue
Validated surrogate endpoint for microvascular disease risk reduction; valid surrogate endpoint for microvascular risk reduction
A1C is a surrogate endpoint for microvascular disease risk reduction
Low blood glucose levels caused by use of antihyperglycemic drugs
Characterized by severely altered mental and/or physical functioning
Blood glucose levels less than 54 mg/dL
Standards & References
External Standards
1A1C should be measured using an assay certified by the NGSP
Specifications
1validated surrogate endpoint for glycemic control
ICH References (4)
Statistical Principles for Clinical Trials; Discourages deterministic procedures due to high risk of bias; Notes that the use of Bayesian methods in clinical trials may be considered.
Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials
Choice of Control Group in Clinical Trials.
The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2