Diabetes Mellitus, Type 2Phase 1/2NCT06329882
Doxycycline in Type II Diabetes
A Phase 1/2 study testing Sitagliptin 100mg and Doxycyclin in people with Diabetes Mellitus, Type 2, run by Mostafa Bahaa at 1 site in Egypt.
Trial summary
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Sitagliptin 100mg and Doxycyclin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2024to 20 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female sex more than 40 years old Newly diagnosed type II diabetes. HbA1c more than 6.5
Who cannot join
- Patient with chronic kidney disease, hepatic disorders, mental and psychiatric disorders, pregnancy, and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Doxycycline in Combination With Sitagliptin on the Glycemic and Cardiac Indices in Patients With Type 2 Diabetes Mellitus
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Sitagliptin 100mg, Doxycyclin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin 100mgDrug
Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes
DoxycyclinDrug
Doxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | patients were on sitagliptin 100mg /day monotherapy Receives: Drug: Sitagliptin 100mg |
| Comparative group | Active comparator | patients were on sitagliptin 100mg /day monotherapy plus doxycycline 100 mg Receives: Drug: Sitagliptin 100mg; Drug: Doxycyclin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic profile
measurement of fasting blood glucose (FBG)
Measured: 3 months
Change in glycemic profile
measurement of glycated hemoglobin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start30 Mar 2024
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329882
- Sponsor's protocol ID
- 14789
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Khateeb E, Khrieba MO, Badawoud AM, Morsy AA, El-Hanafy AA, Hamza E, Habba E, El-Hanafy DA, Eltantawy N, Al-Dhelaan RA, Radwan KH, El-Sayed AA, Eladaroussay MM, Rizk KAK, Ebrahim MHE, Abd Elhameed AG, Erfan IA, Elkhodary NM, Elshorbagi N, Sami HM, Dewidar SA, Mahdy MA, Zakaria H. Repurposing doxycycline as an adjunct to sitagliptin in type 2 diabetes mellitus: a randomized controlled study on glycemic, inflammatory, and cardiometabolic outcomes. Naunyn Schmiedebergs Arch Pharmacol. 2026 Jun 11. doi: 10.1007/s00210-026-05510-7. Online ahead of print.
PubMed 42271067
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline in Combination With Sitagliptin on the Glycemic and Cardiac Indices in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06329882
- Acronym / sponsor ID
- 14789
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mostafa BahaaUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Sitagliptin 100mgpatients were on sitagliptin 100mg /day monotherapy |
| Comparative group | Active comparator | Drug: Sitagliptin 100mg, Drug: Doxycyclinpatients were on sitagliptin 100mg /day monotherapy plus doxycycline 100 mg |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female sex more than 40 years old Newly diagnosed type II diabetes. HbA1c more than 6.5
Key exclusion criteria (1 listed)
- Patient with chronic kidney disease, hepatic disorders, mental and psychiatric disorders, pregnancy, and lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptin 100mgSitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes | Drug | Comparative group, control group |
| DoxycyclinDoxycycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. | Drug | Comparative group |
Primary outcome
Change in glycemic profile
Time frame: 3 months
measurement of fasting blood glucose (FBG)
Change in glycemic profile
Time frame: 3 months
measurement of glycated hemoglobin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 42271067El-Khateeb E, Khrieba MO, Badawoud AM, Morsy AA, El-Hanafy AA, Hamza E, Habba E, El-Hanafy DA, Eltantawy N, Al-Dhelaan RA, Radwan KH, El-Sayed AA, Eladaroussay MM, Rizk KAK, Ebrahim MHE, Abd Elhameed AG, Erfan IA, Elkhodary NM, Elshorbagi N, Sami HM, Dewidar SA, Mahdy MA, Zakaria H. Repurposing doxycycline as an adjunct to sitagliptin in type 2 diabetes mellitus: a randomized controlled study on glycemic, inflammatory, and cardiometabolic outcomes. Naunyn Schmiedebergs Arch Pharmacol. 2026 Jun 11. doi: 10.1007/s00210-026-05510-7. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sitagliptin 100mg and Doxycyclin in people with Diabetes Mellitus, Type 2, run by Mostafa Bahaa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic profile (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06329882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.